Piper Companies is currently looking for an experienced Regulatory Affairs Specialist in King of Prussia, Pennsylvania (PA) to work for an innovative and growing medical device manufacturer. The Regulatory Affairs Specialist will play in pivotal role in the development of new medical implants.
Responsibilities for the Regulatory Affairs Specialist include:
- Cooperate with the product development and management teams to prepare/ review 510k submissions
- Work with personnel in various functional areas to obtain timely submissions to FDA
- Prepare, support, and maintain technical rules in accordance with MDR.
- Review and file Note-to-File documentation for minor changes to 510(k) cleared products or systems.
- Assist in the preparation of FDA reports and or other documentation.
- Ensure conformance to 21 CFR regulations, 1S013485,1S014971, & EU MDR.
Qualifications for the Regulatory Affairs Specialist include:
- BS or higher degree in Health or Science related field
- 5+ years of experience in the medical device experience
- Hands on experience with 510k submissions
- 2+ years of Regulatory affairs experience within the medical device field
Compensation for the Regulatory Affairs Specialist include:
- Salary Range is $80,000-$100,000 dependent upon experience
- Comprehensive benefits package
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Clinical & Life Sciences
King Of Prussia, PA 19946