Regulatory Affairs Specialist

Regulatory Affairs Specialist Job Summary

This position requires a highly skilled Regulatory Affairs Specialist to draft, submit and gain 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.

The ideal candidate will have a working knowledge of products under review and relevant regulations and guidance documents. They must be enthusiastic, positive, even-tempered and effective in building working relationships with internal teams while following FDA 21 CFR regulations.

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;

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;