Regulatory Affairs Manager Job at Intellectt INC, Saint Paul, MN

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  • Intellectt INC
  • Saint Paul, MN

Job Description

Hello,
One of my clients is currently looking for a Regulatory Affairs Manager, If you're interested or if your skills align with the role, please share your updated resume with me at sushma@intellectt.com.


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:
  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.
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.


    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.

Job Tags

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