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: -
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.
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
Shift work,