Compliance

• This position is responsible for ensuring that the business functions comply with internal policies, external regulatory requirements and accepted accounting principles (GAAP/IFRS).
• This role supports month-end close, prepares and validates regulatory and management reporting, designs and test internal controls, coordinates audit activities and drives remediation and process improvements to mitigate financial and compliance risk.
• Support the implementation and continuous improvement of internal control frameworks and policies to strengthen financial controls, reduce risk of misstatement and ensure compliance with evolving regulations.
• Conduct periodic risk assessments of accounting and operations processes to identify compliance gaps, quantify risk exposure, and recommend prioritized remediation and process improvements.
• Lead or support testing cycles, including producing objective evidence, executing walkthroughs and control tests, documenting results in compliance tools and presenting findings to Finance Controller and audit committees.
• Design monitoring and data procedures to proactively detect compliance issues, anomalies or policy breaches.
• Drive remediation projects end to end for identified control deficiencies including root cause analysis, action plan development, stakeholder coordination, timelines and tracking completion to reduce audit findings recurrence.
• Prepare control narratives, flowcharts, control matrices and test plans when needed.
• Execute month-end accounting tasks related to compliance accounts if needed including preparation and review of journal entries, account reconciliations, variance analysis and ensuring entries conform to accounting principles and company policy.

Senior Compliance Audit Associate

• Develop and implement US regulatory strategy for unique products
• Provide strategic regulatory input and execution support to assigned programs
• Coordinate regulatory submissions and manage local marketing authorization applications
• Monitor the development of new regulatory requirements and guidance documents
• Contribute to effective ways of working and consistent regulatory practices

Manager, Global Regulatory Strategy

• 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

• Audit and prepare home health and hospice claims to ensure accurate, compliant, and timely billing
• Requires a high comfort level with making outbound calls to drive timely resolution of documentation and billing needs
• Review face-to-face documentation, unsigned orders, and visit notes; follow up to resolve missing or incomplete information
• Run daily and weekly prebill reports to identify billing issues and help prevent claim denials
• Work closely with Clinical, Marketing, and Administrative teams to remove financial barriers and support patient care
• Meet individual and team productivity goals while maintaining confidentiality and Pathways’ TRUST values

Prebill Compliance Specialist

• Provide regulatory affairs domain expertise and influence at all levels in support of the Wound Management device portfolio
• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations
• Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions
• Participate in negotiations and interactions with regulatory authorities during the development and review process
• Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team
• Support international product registrations as needed
• Manage multiple projects and prioritize tasks on day by day basis to meet project schedules
• Collaborate with engineering, quality, clinical, marketing, and other functions to fulfill responsibilities
• Review promotional and advertising material
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
• Participate in internal and external audits
• Maintain regulatory affairs documentation to support compliance with applicable regulatory requirements
• Perform other duties as assigned or required.

Principal Regulatory Affairs Specialist

• Develop and execute global regulatory strategies for new product development and introduction, including software-based solutions and hardware.
• Advise cross-functional teams on regional regulatory requirements, including FDA (US), EU MDR, NMPA (China), PMDA (Japan), and TGA (Australia).
• Identify and recommend optimal regulatory pathways (e.g., 510(k), PMA, IDE, CE Mark, EU Technical Files, EU Design Dossiers, China NMPA registration, Japan PMDA Shonin, Australia TGA conformity assessments).
• Lead regulatory risk assessments during product design and development, providing solutions to minimize approval delays.
• Author, review, and lead global pre-market regulatory submissions.
• Drive regulatory agency interactions, including FDA Pre-Sub meetings, Notified Body consultations, PMDA pre-consultations, and Scientific Advice processes.
• Represent the company during negotiations and reviews with FDA, Notified Bodies, NMPA, PMDA, and TGA, ensuring alignment on regulatory expectations.
• Represent the Regulatory Affairs function on product development teams, bringing the voice of the function to discussions in an effort to support creative and compliant regulatory strategies for the program.
• Partner with cross-functional team members to lead engagements with regulatory agencies for new and existing devices.
• Lead and influence the preparation of documentation to support innovative and high-quality regulatory submissions from early phase strategies, marketing applications, and change management implementation.
• Engage and actively participate in compliance activities (preparation and execution) including identification of opportunities for improved efficiencies within processes.
• Act as a mentor to colleagues within the team and effectively manages an extended team.
• Stay current on regulation and guidance changes supporting advocacy work as needed to influence evolving regulatory requirements.
• Work with functional team members to ensure clear communication of project/program objectives, deliverables, and timing of key milestones.
• Partner in problem resolution in an effort to mitigate functional/program level challenges to keep objectives moving in line with program estimates.
• Work within a matrixed, collaborative team environment that fosters professional development while focusing on meeting business objectives driven by standards of excellence.

Senior Regulatory Affairs Specialist

• Develop and lead Global and US Regulatory activities for a Development Team (s).
• Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans.
• Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed.
• Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders.
• Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources.
• Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies.
• Provide strategic regulatory input to key development documents and study reports.
• Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally.
• Formulate US regulatory strategy and filings.
• Approval of regulatory documents.
• Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines.

Director, Regulatory Strategist

• Evaluate standard and complex wireless facility projects for compliance with NEPA rules and adherence to CERCLA’s due diligence standards.
• Order and monitor consultants’ services for non-standard wireless facility projects, ensuring deliverables are on schedule and meet quality expectations.
• Evaluate advanced investigation scopes, coordinating with the Compliance management team on proposals exceeding specific scope and cost thresholds.
• Prepare permit applications and mitigation documentation in close coordination with expert environmental consultants.
• Process advanced compliance information and documentation requests from project teams and customers.
• Assist the Compliance management team with preparing responses to inquiries from governmental agencies.
• Develop and deliver project-focused regulatory process and systems training for Regulatory team members and other internal departments.
• Contribute to monthly team meetings focused on project review trends, environmental services trends, cross-functional training needs, and customer service best practices.
• Maintain excellent working relationships with project teams and environmental consultants to move projects through the environmental process.
• Other duties as assigned.

Regulatory Compliance Specialist, Environmental

• Develops and maintains fit-for-purpose regulatory compliance frameworks for consumer, research, and SaMD products
• Partners with engineering, product, and quality teams to operationalize regulatory requirements
• Applies statistical methods and analytical tools to support regulatory decision-making
• Supports post-market regulatory activities for AI/ML-enabled products
• Conducts regulatory landscape assessments for new products and markets
• Monitors and interprets evolving regulatory guidance
• Authors and maintains regulatory documentation

Regulatory Compliance Lead

• Drives quality excellence at Verily by owning one or more Quality Assurance domains and leading strategic QA initiatives
• Responsible for designing and advancing robust quality systems
• Ensures that products are developed, commercialized, and sustained to the highest standards of quality
• Analyzes quality metrics and performance data to identify trends and implement effective corrective actions
• Partners with engineering and product teams to embed quality practices into development workflows

Quality Systems and Compliance Lead

• Collecting, scrubbing, and uploading participant level account data with efficiency and accuracy
• Communicating with plan sponsors and internal stakeholders via Parts+ recordkeeping system
• Reading and comprehending retirement plan provisions from plan documents and amendments
• Ensuring that reports are properly generated according to Eligibility, Compensation, and Contributions
• Ensuring clients meet IRS requirements for compliance activities
• Nondiscrimination testing, Loan Delinquency reporting, and Required minimum Distributions
• Working with the Client Service Manager team & ERISA Government & Reporting team for accurate and timely nondiscrimination testing

Compliance Analyst

• 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.

• Responsible for claims management, and renewal of all university insurance policies (general liability, property, auto, umbrella, international, professional liability, cyber liability, fiduciary liability, workers’ compensation, student professional liability, study abroad, and athletic accident).
• Analyze and assess contractual terms to identify risks, recommend mitigation strategies, and ensure adherence to internal compliance standards and industry regulations.
• Review and renew student health insurance and maintain compliance with state regulations under SHIP; assist with resolution of issues arising from Bursar’s Office, Health Services and/or Athletics.
• Review agreements with external entities necessary for academic programs that require clinical or fieldwork placements.
• Monitor employee work locations to ensure that workers’ compensation coverage is active in appropriate states.
• Request CORI reports for student engagement in clinical experiences; prepare CORI acknowledgement forms for authorized signature.
• Coordinate and manage state filing requirements through third party compliance provider (Labyrinth).
• Maintain active status in sam.gov and submit ori.gov /Office of Research Integrity Annual Report in conjunction with Grants’ Office.
• Provide insurance certificates upon request for various university departments and outside entities.
• Complete insurance claim history requests for former nursing students from prospective employers.
• Serve as Administrator for the university’s wireless account; and as the administrator of the purchasing card program.
• Maintain ERISA three-year bond with insurance company.
• Maintain vehicle registrations for all university owned vehicles and manage the EZ Pass account.
• Prepare the Annual Report filing for submission to the MA Secretary of the Commonwealth.
• Prepare biennial Federal Motor Carrier Safety Administration (FMSCA) report.

Compliance Administrator

• 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

• Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets.
• Provide regulatory affairs support for all aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies.
• Partner with Marketing and Development teams to provide support to currently-marketed products as necessary.
• Compile and submit documentation as required in support of marketing initiatives.
• Review marketing and sales promotional materials for regulatory impact, including: Promotional materials for journals and other media, Trade show booths, materials for distribution, Sales talking points, etc.
• Represent Regulatory Affairs on project teams and in key meetings and decision making processes regarding labeling and promotion.

• 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

• 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.

• 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.
• 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.
• Drive cybersecurity compliance with applicable global regulations, standards, and frameworks, ensuring the organization can demonstrate control effectiveness and audit readiness.

Compliance jobs in Massachusetts

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Senior Compliance Audit Associate

Manager, Global Regulatory Strategy

Manager, Regional Regulatory Lead – LCM

Prebill Compliance Specialist

Principal Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Director, Regulatory Strategist

Senior Regulatory Affairs Specialist

Regulatory Compliance Specialist, Environmental

Regulatory Compliance Lead

Quality Systems and Compliance Lead

Compliance Analyst

Director, Regulatory Affairs

Director, Regulatory Affairs

Compliance Administrator

VP, Governance and Compliance

Senior Regulatory Affairs Specialist

Senior Director, GRC, IT Controls, Cyber Culture

Senior Director, GRC, IT Controls, Cyber Culture

Senior Director, GRC, IT Controls, Cyber Culture