Piper Companies is currently looking for a Regulatory Affairs Specialist in King of Prussia, PA to work for an ISO 13485 certified medical device company committed to creating new technologies and devices for the spine market.
Responsibilities for the Regulatory Affairs Specialist Include:
- Work with Product Development and management to prepare and review 510k submissions.
- Prepare final 510k submissions and obtain required management approvals.
- Submit 510k documents and responses with FDA in a timely manner.
- Obtain & review clinical study data with consulting surgeons, physicians and company clinical affairs advisory committee.
- Review Document Engineering Change Notifications for Regulatory compliance, including drawings and labeling changes.
- Assist in the preparation of FDA reports and or other documentation.
- Ensure conformance to 21 CFR regulations, 1S013485,1S014971, & EU MDR.
- Understand spinal surgical techniques and the use of spinal implant/instrument system
Qualifications for the Regulatory Affairs Specialist Include:
- 5+ years experience in the medical device industry, or equivalent.
- 2+ years experience in Regulatory Affairs in medical device industry or equivalent, preferably with spinal devices.
- BS degree in health or science-related field, or equivalent. Engineering degree is a plus
Compensation for the Regulatory Affairs Specialist Includes:
- Salary is $80,000-$100,000
- Full Benefits
Please send all qualified resumes to Karen Pallone at firstname.lastname@example.org
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Clinical & Life Sciences
King Of Prussia, PA 19406