IntePros is currently looking for a Lead Regulatory Affairs Specialist to join one of our growing medical device/manufacturing clients in Audubon, PA. The Lead Regulatory Affairs Specialist oversees the preparation and submission of regulatory premarket applications, 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.
Lead Regulatory Affairs Specialist 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
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of client
- Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
- Clear understanding of regulatory requirements throughout the product lifecycle
- Strong understanding of regulatory terminology, pre-market submission types, and requirements
- Demonstrated ability to evaluate regulatory impact of proposed product and process changes
- Advanced multi-tasking skills with the ability to project plan and meet deadlines
- Very result driven with a strong sense of responsibility, urgency and ability to perform under pressure
- Typically requires a minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience; or equivalent experience