Regulatory Affairs Manager
2 weeks ago
Role: Regulatory Affairs Manager
Location: St. Paul, MN - 55117
Duration: 6+ Months
Shift Timings: 8 AM to 5 PM
Key Responsibilities:
Leadership & Regulatory Expertise:
- Lead and manage regulatory submissions for Class III medical devices (IDE, PMA, CE Mark, and clinical trial applications).
- Develop and execute regulatory strategies to ensure timely approvals in global markets (FDA, EU MDR, and international pathways).
Compliance Management:
- Monitor and ensure compliance with FDA, QSR, ISO, EN standards, and EU MDR requirements.
- Review and approve engineering studies, manufacturing changes, and validation protocols for Class III devices.
Must-Have Requirements:
Education: Bachelor’s degree (preferably in science, engineering, or medical disciplines). Advanced degree preferred.
Experience: Minimum 7+ years in medical device regulatory affairs, with 5+ years focused on Class III submissions (FDA and EU MDR).
Skills:
- Strong knowledge of global regulatory pathways, including FDA guidance and EU MDR.
- Proven success with regulatory submissions and approvals for Class III devices.
- Experience with change management, QSR, and compliance reviews.
Preferred Skills:
- Working knowledge of regulatory requirements for global markets (e.g., Japan, Canada).
- Strong communication, problem-solving, and organizational skills.
- Ability to manage multiple priorities and drive results.
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