IntePros is currently looking for a Regulatory Affairs Specialist to join one of our growing Medical Device clients in Audubon, PA. The Regulatory Affairs Specialist drafts, submits and gains 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, requires 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.
Regulatory Affairs Specialist Job Responsibilities:
- Partners with Product Development and management to prepare and review 510(k) submissions
- Prepares final 510(k) submissions and obtaining required management approvals
- Submits 510(k) documents and responding to the FDA in a timely manner
- Assists in the completion of IDE and PMA submissions for IDE clinical trials
- Helps to prepare PMA packages, including non-clinical, manufacturing, and clinical sections
- Works with personnel in various functional areas to obtain timely submissions to FDA
- Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting
- Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes
- Performs routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports
- Trains new staff on relevant Regulatory processes as necessary
- Determines Regulatory Pathway for new/changed products under departmental guidelines
- Reviews and approve Regulatory Pathway Forms and supporting documentation
- Reviews and approves Note-to-File documentation for minor changes to 510(k) cleared products or systems
- Understands the company's products, surgical techniques and the use of implant and instrument systems
- Develops relevant Regulatory SOPs as necessary
Regulatory Affairs Specialist Qualifications:
- Bachelor's degree in health or science-related field, or equivalent; Engineering degree is a plus
- Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry preferably within orthopedic medical devices;
- Experience in medical device development and registration of products
- Demonstrated knowledge of US regulatory submissions; Pre-Sub, and 510(k); working knowledge of IDE and PMA submissions a plus
- Experience assessing regulatory impact of product/process changes
- Experience reviewing labeling, promotional literature, etc.
- Excellent communication and listening skills
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
- Strong time management skills, demonstrated ability to work on multiple projects, priorities simultaneously
- Able to work independently as well as within a team