Compliance

• 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 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

• Input information from vendor compliance documents into a hazard communication database
• Review global chemical regulations and determine their application for various products
• Regulatory data clean up and migration support
• Author safety data sheets
• Other hazard communication and regulatory compliance projects as needed

Chemical Regulatory Analyst

• Lead and conduct internal investigations into allegations of ethics and compliance-related misconduct, ensuring timely, objective, and thorough outcomes.
• Plan, organize, and execute investigations, including evidence review, stakeholder interviews, fact-finding, and preparation of detailed investigation reports.
• Draft clear, concise, and evidence-based reports outlining findings, conclusions, and recommendations for leadership review.
• Prepare and present board-level reporting on significant Helpline concerns and communicate complex investigation findings to senior leadership.
• Collaborate with Human Resources, Legal, Internal Audit, Labor Relations, and other key partners to ensure consistency and quality in investigation processes.
• Lead and support complex ethics and compliance investigations, while developing and enhancing investigation processes, programs, and controls that mitigate organizational risk and promote responsible business practices.
• Provide enterprise-wide guidance and subject matter expertise on ethics, compliance, fraud prevention, conflicts of interest, policy interpretation, and other governance-related matters.
• Develop and deliver compliance training, communications, and awareness initiatives that support the effective implementation of policies, procedures, regulatory requirements, and ethical business conduct standards.
• Identify, develop, coordinate and implement practices, procedures and programs to support Company investigations aimed to reduce and limit Company risk and liability.
• Drive proactive compliance and fraud monitoring initiatives, support investigation team objectives, and ensure timely reporting, documentation, and continuous improvement of compliance programs and investigative activities.

Compliance Specialist II

• Provide end user support of the Chemical Data Management System (CDMS)
• Work with users to solve system problems and discover technical issues with software using Microsoft Excel and SQLI Query Analyzer
• Serve as a liaison between day-to-day users of CDMS and IT personnel
• Collaborate with IT professionals to address user problems and solve technical issues
• Work with end users to quantify system performance requirements to ensure compliance with emerging chemical regulations
• Test new versions of client CDMS software and work closely with IT personnel to facilitate smooth functioning of new versions of CDMS
• Provide new version roll-out support to end users located around the globe
• Provide excellent customer service to internal customers through written and verbal communications
• Monitor project status and reports regularly to client and/or Pace leadership

Regulatory IT Analyst

• Provide strategic leadership and oversight for Aqua’s enterprise Compliance Testing and Monitoring program
• Develop and maintain strategic and risk‑based compliance testing plans
• Lead the design, build, and implementation of automated and semi‑automated compliance testing and reporting solutions

Vice President, Enterprise Compliance Testing

• Partners with their assigned Line of Business, other Risk/Compliance/Audit (RCA) professionals, and RCA Managers to create, implement, maintain, review or oversee an effective risk management framework.
• Participates in projects and/or activities that ensure compliance with applicable federal, state, and local laws and regulations.
• Identifies gaps and inform solutions that minimize losses resulting from inadequate internal processes, systems or human errors.
• Identifies, responds and/or escalates risks as appropriate.
• Serves as a functional liaison between the Line of Business and the Lines of Defense.
• Review potential policy violations
• Review and resolution of customer complaints
• Back up reporting as well as other team related tasks.

Compliance Representative

• Prepare, submit, negotiate the terms, secure approval, and resolve any issues that arise for rule, rate, and form filings.
• May assist in providing information for non-financial market regulatory activities, including market conduct exams, interrogatories, surveys, and data calls.
• Support and provide direction to the business units when responding to filing issues, data requests and criticisms from regulatory agencies.
• Analyze state insurance statutes and regulations to determine changes to product design, development and filing requirements, and inform adjustments to current practices accordingly.
• May partner with legal when appropriate.
• Establish and develop partnerships with regulatory bodies and internal business partners such as actuarial, underwriting, product and legal.
• Assist in optimizing regulatory tools and databases by incorporating the latest regulatory changes, industry standards and policy adjustments to enable informed decision-making and adhere to regulatory requirements.
• Assist in the coordination of regulatory and filing projects, track progress, and support the team in meeting deadlines.
• Perform other duties as assigned.

Property and Casualty Regulatory Analyst

• Represent the U.S. compliance function as part of a global compliance framework ensuring alignment with enterprise‑wide standards and risk expectations.
• Serve as a trusted source of compliance advice for senior leaders and management across the business.
• Participate in the development and fulfillment of the annual Compliance plan, including planning, monitoring, reporting, and continuous improvement initiatives.
• Develop and maintain compliance-related policies and procedures and controls to reflect regulatory developments and business needs.
• Conduct compliance risk assessments; identify, evaluate, and monitor emerging and existing risks.
• Perform compliance assurance activities (including reviews, testing, and effectiveness assessments to ensure controls meet regulatory and internal expectations.
• Lead or support regulatory engagement activities, including responses to regulatory inquiries, examinations, and data requests.
• Oversee consumer complaint’s function ensuring issues are appropriately tracked, assessed, escalated, and resolved in collaboration with stakeholders across the business.
• Track legal and regulatory developments ("horizon scanning") and support updates to internal stakeholders and compliance documentation.

Senior Compliance Specialist

• Establish, implement, and maintain risk standards and programs to drive compliance with federal, state, agency, legal, regulatory, and Corporate Policy requirements
• Provide oversight and monitoring of business group risk-based compliance programs
• Develop, oversee, and provide independent credible challenge to standards using subject matter expertise
• Oversee and appropriately challenge Front Line compliance-related decisions and execution
• Maintain compliance risk expertise and provide consulting support for projects and initiatives with moderate to high risk across multiple business lines
• Work with complex business units, rules, and regulations on moderate- to high-risk compliance matters
• Interpret policies, procedures, and compliance requirements
• Provide direction to the business in developing corrective action plans and effectively managing regulatory change
• Monitor the reporting, escalation, and timely remediation of compliance issues, deficiencies, and regulatory matters
• Identify and recommend opportunities for process improvement and risk control enhancement
• Report findings and provide recommendations to management and appropriate governance committees
• Interface with Audit, Legal, external agencies, and regulatory bodies on compliance and risk-related matters
• Collaborate and consult with peers, colleagues, and managers to resolve issues and achieve business objectives
• Make decisions and resolve issues to meet business objectives
• Receive direction from leadership while exercising independent judgment and developing a deeper understanding of the function, policies, procedures, and compliance requirements

Lead Compliance Officer – Auto Operations

• Oversee aspects of the quality system including, but not limited to, change control, supplier quality, records management, equipment and process validation, training and competency program and documentation, internal and external audits, risk management, CAPA, data review, and management review.
• Facilitate the development and update of corporate quality objectives.
• Manage and coordinate with Regulatory for the successful maintenance of ISO 13485 and MDSAP certification including other country requirements as necessary.
• Assist departments throughout the company to identify, document, and implement quality system procedures, including work instructions and forms that ensure compliance to worldwide regulatory requirements (as applicable), as well as guidance documents, standards and common specifications where devices are being marketed. Schedule and lead regular management reviews per procedural requirements.
• Proactively coordinate, collaborate, and communicate with management and teams internally and with our customers and suppliers to resolve problems/complaints and execute projects in a timely and effective manner.
• Communicate key quality scorecard metrics and provide routine management reporting and coordinated corrective and preventive action (CAPA) plans to address areas of deficiencies.
• For significant product issues, coordinate the assessment of the issue, Health Hazard Evaluation, field action, field safety notice, and/or recall efforts, as appropriate.
• Ensure training, as related to quality systems, procedures, and operator certification is effective and completed.
• Ensure organizational capability to support ongoing product development and sustaining engineering programs along with manufacturing support for incoming inspection, product quality, and non-conforming material analysis.
• Maintain a culture of high attention to quality in all aspects of product development and manufacturing.
• Perform miscellaneous duties as assigned by management.

Director, Quality and Compliance

• Configure, maintain, and optimize GRC platforms (preference for IBM OpenPages)
• Support GRC processes including control testing, issue management, and compliance monitoring
• Participate in functional testing, data validation, and regression testing for system enhancements and defect resolution
• Engage in the software development lifecycle (SDLC) by reviewing requirements, testing changes, and supporting production readiness
• Design and implement logical and technical workflows within GRC tools
• Perform root cause analysis to resolve system or process issues
• Apply deep cybersecurity and risk management expertise to assess threats, identify gaps, and recommend mitigation strategies
• Ensure alignment with key industry standards including NIST, CRI, and OWASP
• Provide consultative guidance to business and technical stakeholders on risk, controls, and tool usage
• Deliver clear, concise communications and presentations to leadership and cross-functional audiences
• Apply pre-deterministic and generative AI techniques to enhance analysis, insights, and predictive risk modeling
• Operate effectively in dynamic, fast-changing environments with evolving requirements

GRC Configuration Specialist

• Perform recurring operational activities for the Regulated Entities Cross Functional Compliance Ops and Reporting team
• Represent Compliance in select business line initiatives and support coordination of compliance-related requirements
• Provide flexible support across the team based on business priorities and capacity needs
• Assist with process improvements, issue follow-up, monitoring activities, and related documentation

Regulated Entities Compliance Operations Specialist

• Obtain, analyze, refine, and report information at an appropriate level of granularity for the Risk Management Committee of the Board, senior operating committee/subcommittees, and additional executive reporting as needed
• Ensure materials are clear, consistent, and appropriate for senior leadership presentation
• Monitor the Compliance issue population, customer remediation events, regulatory examinations, audits, and key initiatives to filter information into relevant reporting
• Collaborate with Compliance leadership and risk partners across the organization to ensure an understanding of relevant topics for consideration in reporting routines
• Ensure governance routines are maintained for the Compliance senior operating committee (Compliance Risk Management Committee) and related subcommittee(s)
• Maintain a comprehensive understanding of monthly and quarterly Compliance metrics
• Monitor results and draft commentary for breaches or positive/negative trends
• Prepare materials and present as needed in senior operating committee, regulatory meetings, and other executive meetings as needed
• Maintain adequate procedures and oversight of control activities/documentation

Compliance Executive, Reporting Manager

• Support the Customer Global Product Stewardship Team by reviewing, organizing, and summarizing documents, and preparing reports and assessments
• Conduct toxicology and risk assessments for medical devices and manufacturing processes
• Prepare Chemical Hazard Summaries and Biological Evaluation Reports, including data tables and literature reviews
• Compile and summarize biocompatibility test data and study results
• Perform qualitative toxicology assessments using existing data, regulatory classifications, and scientific literature
• Conduct gap analysis involving cross-referencing chemicals against PCTEC, CHS, and hazard summary data

Chemical Regulatory Coordinator

• Input information from vendor safety data sheets into a hazard communication database
• Review global chemical regulations and determine their application for various products
• Search for SDS sheets of raw materials
• Fill in missing or incorrect information in the SDS sheets
• Contact vendors as needed

Entry Level Chemical Regulatory Analyst

• Conduct consumer compliance reviews, regulatory testing, risk assessments, and issue validation activities
• Evaluate business processes and controls for compliance with applicable federal and state consumer finance regulations
• Identify compliance risks, document findings, and support remediation efforts
• Provide regular status updates to Senior Compliance Examiners and management throughout the review lifecycle
• Prepare clear, accurate, and well-documented workpapers that outline testing procedures performed, results obtained, and supporting analysis
• Maintain working knowledge of relevant regulatory requirements, regulatory changes, and business initiatives, and understand their potential compliance impacts
• Identify compliance risks and control gaps based on testing results and observations, and communicate findings to the review lead
• Provide timely status updates on assigned testing activities to management
• Contribute to the development of comprehensive and defensible testing reports
• Establish and maintain effective working relationships with business partners and internal stakeholders during the course of reviews
• Respond to business partner inquiries regarding compliance requirements and regulatory expectations
• Review and analyze policies, procedures, workflows, and first-line monitoring activities
• Research regulatory and operational questions and summarize findings; provide recommendations or escalate complex issues as appropriate
• Develop corrective action recommendations, review management action plans, and validate remediation efforts through issue closure
• Support special projects and perform other duties as assigned

Compliance Examiner

• Lead and develop a high-performing team focused on product release and regulatory execution
• Lead end-to-end regulatory product release strategy and execution, ensuring compliance with global regulatory requirements
• Drive process standardization, simplification, and automation across product release workflows
• Lead data quality initiatives to support compliant global submissions and product distribution
• Oversee regulatory distribution control processes (e.g., GTS/SAP) to enable timely and accurate product release
• Lead continuous improvement initiatives focused on cycle time, quality, and scalability of release processes
• Establish and monitor KPIs, dashboards, and reporting to track performance and compliance
• Build organizational capability in regulatory systems, data, and operational execution

Compliance jobs in Minnesota

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Principal Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

VP, Governance and Compliance

Chemical Regulatory Analyst

Compliance Specialist II

Regulatory IT Analyst

Vice President, Enterprise Compliance Testing

Compliance Representative

Property and Casualty Regulatory Analyst

Senior Compliance Specialist

Lead Compliance Officer – Auto Operations

Director, Quality and Compliance

GRC Configuration Specialist

Regulated Entities Compliance Operations Specialist

Compliance Executive, Reporting Manager

Chemical Regulatory Coordinator

Entry Level Chemical Regulatory Analyst

Compliance Examiner

Senior Regulatory Affairs Manager