Compliance

• execution of closed loop audit and assessment programs , including Technology Supplier Audit and GxP system Periodic Reviews.
• providing direct support to business segments during global health authority inspections and other third-party audits related to Technology areas.
• compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate.
• assists in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions.
• reports to the Head, Med Tech & Emerging Compliance.
• Executes closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, audit and assessment corrective actions, documenting results, reporting on follow-up status, escalating critical issues/risk to senior leadership.
• Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers.
• Partners with Technology Quality and Business Quality to execute gap assessments between current practices and new regulatory expectations.
• Works with Quality partners to establish corrective actions to address any identified gaps.
• Leads the resolution of complex situations that arise during execution of closed loop audit and assessment programs.
• Ensure awareness of industry standards, trends and best practices in order to strengthen GxP knowledge.
• Participate in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions.
• Provide compliance input and final review of formal responses to health authority observations related to Enterprise Quality Compliance.
• Provides compliance subject matter expertise and support to Technology Quality and sector Business Partners related to GxP processes in the end-to-end technology areas.
• Proactively sense for opportunities and actively participate in compliance program development from the outset.

Lead Technology Compliance

• Analyze quantitative and qualitative data (e.g., health authority information and trade association updates) to identify trends, risks, and outliers, and translate findings into actionable insights with clear implications and recommended actions for stakeholders
• Prepare recurring and ad hoc reports, dashboards, and executive-ready presentations that effectively communicate regulatory intelligence insights to support decision-making
• Ensure data accuracy, integrity, and traceability through robust extraction, validation, and reconciliation processes, while maintaining standardized templates, definitions, and methodologies
• Partner with the Senior Director and/or Directors to define requirements, manage competing priorities, and deliver high-quality analyses on time while enabling consistent execution through cross-sector collaboration
• Apply approved AI and digital tools to enhance reporting workflows and support implementation of regulatory intelligence systems

Manager, Regulatory Intelligence

• execution of closed loop audit and assessment programs , including Technology Supplier Audit and GxP system Periodic Reviews.
• providing direct support to business segments during global health authority inspections and other third-party audits related to Technology areas.
• compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate.
• assist in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions.
• execution of closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, audit and assessment corrective actions, documenting results, reporting on follow-up status, escalating critical issues/risk to senior leadership.
• Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers.
• Partners with Technology Quality and Business Quality to execute gap assessments between current practices and new regulatory expectations.
• Works with Quality partners to establish corrective actions to address any identified gaps.
• Leads the resolution of complex situations that arise during execution of closed loop audit and assessment programs.
• Maintain awareness of new and emerging technologies and regulatory requirements.
• Participate in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions.
• Ensure timely and effective support is provided to J&J Operating Companies globally.
• Provides compliance input and final review of formal responses to health authority observations related to Enterprise Quality Compliance Expertise.

• Support clients in maintaining compliance with federal, state, and local environmental regulations
• Contribute to sustainability and environmental risk management initiatives across industries
• Partner with experienced consultants and subject matter experts to deliver high-quality project outcomes
• Play a hands-on role in field investigations and data collection that inform critical environmental decisions
• Help drive continuous improvement in EHS management systems and compliance programs

Consultant, Environmental Health and Safety – Compliance

• Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus.
• Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) and other regional, labeling and CMC GRAST members.
• Ensure bi-directional communication with stationed region commercial operations and GRA.
• Engage with health authority (HA) in stationed country (FDA or EMA).
• Contribute to product health authority interaction with support GRL or Regulatory TA Head.
• Partner with GRAST members to achieve regulatory deliverables.
• Update and maintain applicable regulatory systems (e.g., Veeva) to ensure tracking and compliance deliverables.

Manager, Regional Regulatory Lead – LCM

• Provide strategic direction and leadership for the Technology Compliance team, which acts as the SDLC and IT Controls subject matter experts.
• Hold full accountability for the service line’s resource management and talent development.
• Oversee IT GRC’s SDLC advisory service to enable IT customer success by making SDLC and IT Controls compliance simple to execute.
• Provide thought leadership and direction on the application of SDLC and IT Controls for emerging technologies and large company initiatives with technology components.
• Direct core operational compliance functions, including the Compliance Validation Service, IT Controls implementation, Compliance Issue management, and Infrastructure Oversight.
• Oversee the IT audit support function that serves as the primary liaison and facilitator for internal and external audits.
• Drive continuous audit readiness through robust controls assessments and preparation for internal audits and external inspections.
• Partner with risk and compliance technology teams to improve adoption of those tools and to provide valuable user feedback for continuous improvement.
• Drive policy and controls training and awareness programs across the IT enterprise to build a proactive culture of compliance.
• Build and maintain strong, collaborative relationships with key stakeholders across IT, Quality, Finance, and the business to ensure alignment on compliance objectives and risk posture.

Director, Technology Compliance

• Serve as a proactive, trusted advisor to business partners by delivering practical, risk-informed guidance that enables strategic objectives while appropriately managing compliance risk.
• Build a deep understanding of assigned business strategies, priorities, and operating models to provide practical, risk-informed guidance that supports innovation, growth, and successful business execution.
• Proactively engage business teams early in strategy development and initiatives planning to identify opportunities, anticipate compliance considerations, and help shape practical solutions before execution.
• Exercise sound judgement in ambiguous situations by balancing business objectives, patient impact, regulatory expectations, and organizational risk tolerance.
• Embed principles-based decision making into business activities by applying sound judgment and aligning guidance to risk, rather than prescriptive rules.
• Assess emerging compliance risks and translate policy requirements into practical guidance that enables timely business execution.
• Drive execution of compliance initiatives, action plans, and cross-functional deliverables, ensuring high quality execution, accountability, and measurable progress against business and compliance priorities.
• Lead or support the HCC Framework inclusive of risk assessments, HCC projects, risk-tiered oversight, and monitoring activities and contribute to continuous improvement of the compliance program.
• Identify opportunities to simplify, modernize, and continuously improve compliance processes, tools, and governance to better support evolving business needs.
• Partner effectively across Global Functions, Legal, Finance, Business Development and cross-functional stakeholders to advance strategic priorities while promoting compliant and ethical business practices.
• Influence stakeholders through credibility, collaboration, and thoughtful challenge to promote compliant, ethical, and commercially informed business practices.
• Contribute to a culture of accountability, integrity, and ethical decision-making, including through coaching, training, reinforcement of compliance expectations and speak-up culture.

Senior Manager, Health Care Compliance Officer – Global Functions

• Oversee and coordinate all activities within the Retirement Operations team
• Ensure delivery of compliance tests and employer calculations
• Manage budget, including developing budget proposals and monitoring accounts
• Identify and develop solutions to address risks and assist in the creation of solutions

Director, Compliance Services

• Ensuring compliance with regulatory requirements for promotional and non-promotional materials
• Leading discussions for assigned products during the Promotional Material Review Team (PMRT)
• Supporting interactions with regulatory authorities
• Preparing regulatory submissions for promotional materials
• Developing and delivering training programs on promotional regulations
• Monitoring enforcement actions and industry trends

Associate Director, Global Regulatory Advertising and Promotion

• Draft cover letters and support the preparation of various applications (ie: IND, CTA, MAA/NDA and eCTD), and procedures for Regulatory Agency submissions.
• For CTA/INDs – Ensure protocols are in alignment with regulatory requirements and provide advice on required documents and submission strategies in preparation for those filings.
• For Marketing Authorization Applications (NDA, MAA or other major HA submissions): Provide regulatory support throughout the registration process.
• Advise team on required documents and submission strategies in preparation of NDA, MAA (and other global filings) as assigned (in collaboration with LOCs as appropriate).
• Assist with timely NDA, MAA (other) availability, ensure that all document components are in place on time, identify and track critical path activities.
• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other).
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.
• Assist in the preparation of meetings with Regulatory Agencies.
• Coordinate, contribute to development, and review the content of responses to queries from HAs to ensure high quality and timely responses.
• May include other activities as delegated by the RRL/GRL.
• Liaise with LOCs, track dates of submissions/responses to queries in a timely manner.
• Acts as back up contact/representative on specific multi-discipline teams, or with regulatory agencies as needed.
• May be responsible for organizing and leading meetings.
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.
• Supports GRL(GRT) by driving high project management planning of global submissions or Health authority interactions and additional major regulatory milestones.
• Participate in global regulatory team meetings as appropriate.
• Assist in strategy development by researching regulatory and medical information in preparing submissions to Global Health Authorities (HAs).
• Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned.
• Partner with regulatory colleagues to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences, and disease area-specific issues.
• May assist in the development and improvement of regulatory processes.

Manager, Global Regulatory Scientist – Regulatory Affairs

• Define the strategic regulatory direction for pipeline development and global launch excellence.
• Serve as member of TECA+S RA LT, TECA+S PLTs, including Sports/Soft Tissue, Trauma, CMFT, Bio and Spine (as needed) PLTs.
• Partner with R&D and Global Strategic Marketing leaders as well as other functional leaders to develop and implement strategy for pipeline development and global launch excellence.
• Exercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manages, oversees and balances resource allocation across critical projects; and is responsible for regulatory aspects of product lifecycle management.
• Lead and develop Regulatory staff to become future leaders.
• Partner with Policy to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's research and development programs to management.
• Establish and ensure deployment of learning initiatives and training of cross functional partners on current and emerging regulatory and related requirements.
• Responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies.
• Ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements.
• Assure timely regulatory clearances for key product launches in all key markets and assesses the current state of the department (organizational structure, competencies and skills) and implements a strategic vision and tactical plans consistent with the organizational and RA strategic objectives.
• Inspire, motivate and communicate vision to regulatory associates, peers.
• Identify and assess external innovation opportunities connected to the area of responsibility– both screening & technical due diligence (or designate team member).
• Represent Johnson & Johnson’s strategic focus area in various internal and external forums and strategy/interactions.
• Strategic thinking and ability to partner and Influence key stakeholders at senior levels.
• Leverage expert scientific and technical understanding of medical devices and/or biologics to serve as an expert resource and strategic partner for development and planning throughout the product lifecycle in applicable markets (for example, partnering with business partners to proactively address safety issues).
• Build, sustain, and reward a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
• Leverage expertise to educate and coach others on the development and execution of business plans and Regulatory Affairs strategies with a focus on innovative results.
• Advise and challenge others, including cross functional business partners, to ensure the best business-level best decisions are consistently made within the organization and based on the Credo.
• Makes and stands behind complex and difficult decisions in ambiguous situations with a large potential impact on the organization.

Director, Regulatory Affairs

• Define the strategic regulatory direction for pipeline development and global launch excellence.
• Serve as member of TECA+S RA LT, TECA+S PLTs, including Sports/Soft Tissue, Trauma, CMFT, Bio and Spine (as needed) PLTs.
• Partner with R&D and Global Strategic Marketing leaders as well as other functional leaders to develop and implement strategy for pipeline development and global launch excellence.
• Exercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit.
• Manage, oversee and balance resource allocation across critical projects.
• Lead and develop Regulatory staff to become future leaders.
• Partner with Policy to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations.
• Ensure company policies, procedures and practices are in compliance with appropriate regulatory requirements.
• Assure timely regulatory clearances for key product launches in all key markets.

• Develop and lead Casepoint’s enterprise Governance & Compliance strategy, ensuring scalable governance practices that support business growth and customer trust.
• Own enterprise privacy, compliance, AI governance, information governance, and corporate policy programs.
• Establish governance frameworks for emerging technologies, including responsible AI, data governance, and regulatory compliance.
• Partner with Executive Leadership to proactively identify, assess, and manage regulatory, contractual, operational, and technology-related risks.
• Provide executive oversight of the contracts function by partnering with the Director of Government Contracts on strategy, governance, risk management, and operational priorities.
• Collaborate with Sales, Product, Finance, Security, Legal, Engineering, and Customer Success to enable growth while balancing business objectives with appropriate governance.
• Develop executive reporting, governance metrics, and compliance dashboards to support informed decision-making.
• Drive continuous improvement through scalable processes, automation, and technology-enabled governance solutions.
• Monitor evolving regulatory requirements and industry best practices, recommending proactive enhancements to governance programs.

VP, Governance and Compliance

• Proactively monitor, synthesize, and prioritize global enforcement signals and inspection outcomes (e.g., inspection observations, recalls, and warning letters) to produce predictive insights and identify emerging inspectorate focus areas.
• Develop actionable insights for site inspection readiness programs, including themes, readiness expectations, recommended mitigations, and monitoring of progress aligned to observed enforcement trends.
• Translate enforcement trends into capability-building deliverables (e.g., targeted deep-dives, inspection readiness playbooks, and training) for sector/site readiness teams and site/corporate auditors.
• Support the design and maintenance of an early-warning system that combines manual curation and automated analytics (machine learning, trend detection) to surface emerging inspectorate priorities.
• Partner with internal audit leaders to inform risk-based audit planning and refine audit focus areas based on external enforcement signals and evolving inspectorate priorities.
• Provide enterprise regulatory insights and analysis in collaboration with Enterprise Compliance, offering a comprehensive, strategic view of global compliance posture, key risks, and priority actions across the enterprise.
• Produce periodic enforcement trend reports, dashboards/briefings, and executive-ready communications for senior leaders and regulatory intelligence stakeholders.

Director, Regulatory Intelligence Enforcement

• Implementation of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.
• Represent the regions and contribute to the regional and global regulatory strategy through participation in product-related teams.
• Advise product teams regarding regional and local requirements and impact of supply chain decisions on regional registrations to efficiently implement regional regulatory strategies.
• Lead the Regional Working groups to ensure timely execution of product objectives and align regional deliverables with those of the global teams.
• Facilitate tactical implementation at the regional level and ensure ongoing and effective communications with the regional and global teams on product activities and issues.
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints.
• Liaise directly with Local operating companies as needed and assist in the preparation for meetings with regulatory agencies in the regions.
• Oversee management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.
• Development of regional marketing approval submission plans in collaboration with Regional and Global regulatory teams, including submission plans and preparation submission documents.
• Preparation of registration dossiers and dossier re-use strategies.

Manager, Regional Regulatory Affairs – Cross-Regional Operations and Strategy Support

• Build and mature the enterprise GRC function, including governance forums, risk management processes, compliance oversight, control monitoring, issue management, and executive reporting.
• Provide leadership and oversight for the BISO manager organization, ensuring consistent engagement with business leaders, effective cyber risk advisory support, and alignment of security priorities to business objectives.
• Lead enterprise cyber risk management activities, including risk identification, assessment, mitigation planning, escalation, and reporting to senior leadership and governance bodies.
• Own the enterprise cybersecurity policy and standards lifecycle - from creation and implementation to continuous review - ensuring clarity, compliance, and alignment with organizational goals.
• Oversee SOX cybersecurity and IT control activities, including implementation, operating effectiveness, evidence readiness, remediation tracking, and partnership with Finance, Internal Audit, External Audit, and IT control owners.
• Establish and operationalize an enterprise IT controls and assurance framework that enables consistent control design, testing, monitoring, reporting, and continuous improvement across the organization.
• Lead oversight of external cybersecurity assessments and assurance requests, including cyber insurance questionnaires, ESG-related cybersecurity inputs, customer or partner assessments, and other third-party reviews requiring enterprise cyber risk and control representation.
• Drive cybersecurity compliance with applicable global regulations, standards, and frameworks, ensuring the organization can demonstrate control effectiveness and audit readiness.
• Lead security awareness, behavior, and culture initiatives that improve workforce accountability, reduce human-centric risk, and embed secure practices into day-to-day business operations.
• Lead and develop high-performing cybersecurity leaders and teams, fostering a culture of accountability, collaboration, disciplined execution, and continuous improvement.
• Provide executive-level reporting on cybersecurity risk, compliance status, control effectiveness, assurance outcomes, and program maturity to senior leadership and governance bodies.

Senior Director, GRC, IT Controls, Cyber Culture

• Review and approve company, product, and producer advertising material for compliance with state and federal advertising laws and regulations.
• Determine whether regulatory filings of advertising are required and coordinate as needed.
• Build and maintain rules in the advertising review system.
• Maintain final copies of advertising and other related documentation.
• Participate in regulatory and corporate audits for advertising compliance.
• Review and analyze current policies and procedures; identify, recommend and implement new and/or enhanced practices.
• Research, analyze and interpret current, new, and proposed regulatory requirements (e.g., statutes, regulations, bulletins) to determine impact to the organization and advise business partners.
• Update and maintain complete and accurate policies, procedures, compliance logs or files.
• Assist team members with research and assigned tasks; provide training to supported teams.
• Perform special projects as assigned.

Senior Compliance Analyst – Advertising Reviewer

• Build and mature the enterprise GRC function, including governance forums, risk management processes, compliance oversight, control monitoring, issue management, and executive reporting.
• Provide leadership and oversight for the BISO manager organization, ensuring consistent engagement with business leaders, effective cyber risk advisory support, and alignment of security priorities to business objectives.
• Lead enterprise cyber risk management activities, including risk identification, assessment, mitigation planning, escalation, and reporting to senior leadership and governance bodies.
• Own the enterprise cybersecurity policy and standards lifecycle - from creation and implementation to continuous review - ensuring clarity, compliance, and alignment with organizational goals.
• Establish and operationalize an enterprise IT controls and assurance framework that enables consistent control design, testing, monitoring, reporting, and continuous improvement across the organization.
• Drive cybersecurity compliance with applicable global regulations, standards, and frameworks, ensuring the organization can demonstrate control effectiveness and audit readiness.
• Lead security awareness, behavior, and culture initiatives that improve workforce accountability, reduce human-centric risk, and embed secure practices into day-to-day business operations.
• Provide executive-level reporting on cybersecurity risk, compliance status, control effectiveness, assurance outcomes, and program maturity to senior leadership and governance bodies.

Compliance jobs in Pennsylvania

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Lead Technology Compliance

Manager, Regulatory Intelligence

Lead Technology Compliance

Consultant, Environmental Health and Safety – Compliance

Manager, Regional Regulatory Lead – LCM

Director, Technology Compliance

Senior Manager, Health Care Compliance Officer – Global Functions

Senior Manager, Health Care Compliance Officer – Global Functions

Director, Compliance Services

Associate Director, Global Regulatory Advertising and Promotion

Manager, Global Regulatory Scientist – Regulatory Affairs

Director, Regulatory Affairs

Director, Regulatory Affairs

VP, Governance and Compliance

Director, Regulatory Intelligence Enforcement

Director, Regulatory Intelligence Enforcement

Manager, Regional Regulatory Affairs – Cross-Regional Operations and Strategy Support

Senior Director, GRC, IT Controls, Cyber Culture

Senior Compliance Analyst – Advertising Reviewer

Senior Director, GRC, IT Controls, Cyber Culture