Piper Companies is looking for a Regulatory Affairs Specialist to assist in writing and obtaining clearance for the 510(k) submissions to the FDA for class II & class II medical device products for a Device Manufacturer in King of Prussia, PA.
Responsibilities for the Regulatory Affairs Specialist include:
- Work with R&D and management to prepare/review 510(k) submissions
- Prepare final 510(k) submissions
- Interact with FDA to submit 510(k) documents and responses in timely manner
- Work with consulting surgeons, physicians to obtain and review clinical study data
- Train new staff of new, relevant Regulatory processes as necessary
- Assist in preparation of FDA reports
- Ensure conformance to 21 CFR regulations, 1S013485,1S014971, & EU MDR.
- Review and file Note-to-File documentation for minor changes to 510(k) cleared products or systems
Qualifications for the Regulatory Affairs Specialist include:
- Bachelor’s Degree in Heath or Science-related field, Engineering degree is a plus
- Minimum 5 years experience in the Medical Device industry (Spinal devices preferred)
- Minimum 2 years experience in Regulatory Affairs
- Excellent verbal, written and organizational skills
- Good computer skills
- Must be detailed oriented
Compensation for the Regulatory Affairs Specialist include:
- 6 month Contract-to-Hire
- Hourly range: $38.46/hour - $48.08/hour ($80,000 - $100,000)
Please send resume to Derek Herbine: firstname.lastname@example.org
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Clinical & Life Sciences
King Of Prussia, PA 19406