|The Regulatory Affairs Specialist assists in writing, submitting and gaining clearance for 510(k) submissions and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with internal teams while following FDA 21 CFR regulations. Experience should demonstrate dependability, flexibility and maturity. Individual must be able to travel up to 10-20% of the time.
- Work with Product Development and management to prepare and review 510(k) submissions.
- Prepare final 510(k) submissions and obtain required management approvals.
- Submit 510(k) documents and responses with FDA in a timely manner.
- Assist in completion of IDE and PMA submissions for IDE clinical trials.
- Help prepare PMA packages, including non-clinical, manufacturing, and clinical sections.
- Work with personnel in various functional areas to obtain timely submissions to FDA.
- Obtain and review clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting.
- Review Document Change Orders for Regulatory compliance, including drawings and labeling changes.
- Routine maintenance of approved PMAs, including coordination and preparation of PMA supplements.
- Train new staff on relevant Regulatory processes as necessary
- Assist in Regulatory Pathway Form determinations under departmental guidelines.
- File copies of all signed Regulatory Pathway Forms and supporting documentation.
- Review and file Note-to-File documentation for minor changes to 510(k) cleared products or systems.
- Assist in the preparation of FDA reports.
- Ensure conformance to 21 CFR regulations.
- Understand spinal surgical techniques and the use of spinal implant/instrument systems.
- BS degree in health or science-related field, or equivalent. Engineering degree is a plus.
- Minimum of 5 years experience in the medical device industry, or equivalent.
- Minimum of 2 years experience in Regulatory Affairs in medical device industry or equivalent, preferably with spinal devices.
- Excellent verbal, written and organizational skills.
- Good computer skills.
- Must be detail-oriented.
Please send qualified resumes to Karen Pallone at firstname.lastname@example.org