Regulatory Affairs Project Manager

Regulatory        ·         Minneapolis, MN (Headquarters)        ·        Full time

This position is responsible for managing the development, implementation, update and maintenance of CVRx regulatory systems and activities.  Will maintain and disseminate all assigned regulatory document submissions and filings, both electronic and paper.  Ensures compliance with all U.S. and international regulatory requirements pertaining to clinical studies, product approvals, marketing, labeling, and post-approval reporting.

Key Duties and Responsibilities

• Support CVRx interface with with FDA, and other international agencies, as necessary.
• Assist with review and interpretation of regulatory rules and ensure that they are communicated through company policies and procedures. Proactively communicate with internal departments to become and remain educated about key regulatory issues affecting these areas.
• Assist and or perform Device Listing (FDA), Establishment Registration (FDA), international registration support, advise on adverse event reporting and manage remedial actions as required.
• Maintain a general knowledge of federal and state regulations regarding QSR, BS/EN/ISO 13485, and applicable international standards and regulations as required by specific country market requirements and quality assurance issues.
• Organize, prepare, and review regulatory submissions and reports; including Pre-market Approval Applications, 510(k)s, Investigational Device Exemptions, Medical Device Reports, Vigilance Reports, Post-Approved Reports and international submissions.
• Prepare copies of regulatory submissions for dissemination to regulatory agencies or other required parties.
• Assist with development, review, approval, and control of device labeling, marketing literature, website, social media, and other information for regulatory impact.
• Ensure electronic documents are appropriately formatted for electronic publishing meeting the regualtory authority requirements, communicate with other departments regarding format expectations, development of style guides or other aids to achieve this objective.
• Perform miscellaneous duties as assigned by the leadership of regulatory affairs.

Education and Experience

Required:

• BS in life sciences, engineering, or equivalent is preferred.
• Minimum five years related experience in the medical device industry.
• Relevant working experience with FDA and other international agencies and the specific requirements of CFR 21 and other international requirements, as they relate to medical devices.

Preferred:

• Proficient in an MS Office environment, including Outlook, Word, Excel, Acrobat Pro, and PowerPoint applications.
• Demonstrated initiative and ability to work both independently and as an interdisciplinary team member in carrying out assigned regulatory responsibilities.
• Excellent interpersonal and written communication skills, highly motivated and organized.
• Considerable knowledge of pertinent regulations (such as QSR, MDR, labeling, 510(k), PMA, IDE as well as relevant international standards and directives).
• Trained in the FDA Quality System Regulation, BS/EN/ISO 13485 (including Medical Device Single Audit Program (MDSAP)), Quality System Standard, and applicable international standards and regulations as required by specific country market requirements.

Working Conditions

• Normal office conditions.
• Must be fully vaccinated per CDC guidance against the COVID-19 virus and willing to comply with pre-employment screening, including but not limited to reference verification and background check.

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