Position Summary:The Senior 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.
Essential Functions:- 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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- 5+ years of related experience in the medical device industry
- Bachelor's degree required
- Understanding of regulatory requirements throughout the product lifecycle
- Solid understanding of regulatory terminology, pre-market submission types, and requirements
- Able to evaluate regulatory impact of proposed product and process changes
- Capable multi-tasking skills with the ability to project plan and meet deadlines
- Result driven with a sense of responsibility, urgency and ability to perform under pressure
Physical Demands:The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
