Medical Device Regulatory Professional
1 week ago
Job Summary:
Elevate Search is partnering with a leading medical device company to find a Regulatory Affairs Project Manager. This individual will report to the Director of Regulatory Affairs and play a critical role in the FDA approval process of a groundbreaking implantable device.
Key Responsibilities:
- Engage in regular meetings with the FDA to ensure compliance with regulatory requirements
- Participate in clinical trials and provide regulatory expertise
- Collaborate closely with the leadership team to drive the PMA application process
- Develop and implement regulatory strategies to ensure compliance with US regulations
- Provide guidance on regulatory matters to cross-functional teams
Requirements:
- Bachelor's degree in a scientific discipline
- Prior US experience in regulatory affairs
- Proven experience with PMA applications
- At least 5 years of experience in regulatory affairs
- Willingness to work onsite in Irvine at least 3 days a week
What We Offer:
- Exceptional benefits package, including medical, dental, and vision insurance
- 401K match and annual bonus
- PTO and 13 paid holidays
- A transparent and visible leadership team
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