Role: Regulatory Affairs Manager (Project Manager, Individual Contributor)
Location: St. Paul, MN
Duration: 6 Months
Shift: 08:00 AM to 05:00 PM

1. Regulatory Expertise:

   • Develop and implement regulatory strategies for timely product approval.
   • Prepare and submit regulatory documentation (IDE, PMA, CE Mark applications, EU MDR clinical trial applications, etc.).
   • Ensure compliance with FDA, EU MDR, and other international regulatory requirements.

2. Project Management:

   • Lead cross-functional teams to achieve submission and compliance goals.
   • Manage multiple regulatory projects, ensuring adherence to timelines and standards.
   • Provide guidance on regulatory requirements for Class III implantable medical devices.

3. Stakeholder Engagement:

   • Collaborate with internal departments (Engineering, Manufacturing, etc.) and external regulatory agencies.
   • Build strategic partnerships to advance organizational objectives.

4. Compliance Oversight:

   • Review and approve manufacturing changes, study protocols, and validation reports.
   • Monitor regulatory developments and communicate updates across the organization.

5. Leadership & Development:

   • Mentor team members and foster a diverse and inclusive workplace.
   • Participate in strategic decision-making and operational policy development.

• Education: Bachelor's degree in medical, science, or engineering-related discipline (Advanced degree preferred).
• Experience:
  • 9+ years of regulatory experience, with 5+ years specific to Class III medical devices.
  • Proven success in FDA and EU MDR submissions (e.g., IDE, PMA, CE Mark).
  • Experience with QSR, ISO, and EN standards.
  • Familiarity with regulatory requirements in Japan, Canada, and other international markets is advantageous.
• Skills:
  • Strong written, verbal, and organizational skills.
  • Excellent project management and cross-functional collaboration abilities.
  • Expertise in change control, manufacturing operations, and engineering protocols.
  • Ability to manage competing priorities and adapt to change.

• Direct experience authoring successful submissions for Class III implantable devices under EU MDR.
• Working knowledge of FDA guidance documents, CFR regulations, and other international standards.
• Strong communication and leadership skills to influence and guide cross-functional teams.

  
  Role: Regulatory Affairs Manager (Project Manager, Individual Contributor)
  Location: St. Paul, MN
  Duration: 6 Months
  Shift: 08:00 AM to 05:00 PM

  Core Responsibilities:

• Regulatory Expertise:

  • Develop and implement regulatory strategies for timely product approval.
  • Prepare and submit regulatory documentation (IDE, PMA, CE Mark applications, EU MDR clinical trial applications, etc.).
  • Ensure compliance with FDA, EU MDR, and other international regulatory requirements.

• Project Management:

  • Lead cross-functional teams to achieve submission and compliance goals.
  • Manage multiple regulatory projects, ensuring adherence to timelines and standards.
  • Provide guidance on regulatory requirements for Class III implantable medical devices.

• Stakeholder Engagement:

  • Collaborate with internal departments (Engineering, Manufacturing, etc.) and external regulatory agencies.
  • Build strategic partnerships to advance organizational objectives.

• Compliance Oversight:

  • Review and approve manufacturing changes, study protocols, and validation reports.
  • Monitor regulatory developments and communicate updates across the organization.

• Leadership & Development:

  • Mentor team members and foster a diverse and inclusive workplace.
  • Participate in strategic decision-making and operational policy development.
• Required Qualifications:
• Education: Bachelor's degree in medical, science, or engineering-related discipline (Advanced degree preferred).
• Experience:
  • 9+ years of regulatory experience, with 5+ years specific to Class III medical devices.
  • Proven success in FDA and EU MDR submissions (e.g., IDE, PMA, CE Mark).
  • Experience with QSR, ISO, and EN standards.
  • Familiarity with regulatory requirements in Japan, Canada, and other international markets is advantageous.
• Skills:
  • Strong written, verbal, and organizational skills.
  • Excellent project management and cross-functional collaboration abilities.
  • Expertise in change control, manufacturing operations, and engineering protocols.
  • Ability to manage competing priorities and adapt to change.
• Preferred Qualifications:
• Direct experience authoring successful submissions for Class III implantable devices under EU MDR.
• Working knowledge of FDA guidance documents, CFR regulations, and other international standards.
• Strong communication and leadership skills to influence and guide cross-functional teams.