SUMMARY: The Regulatory Affairs Specialist will provide regulatory support for new and existing products. Responsibilities include:
Implementing regulatory plans
Completing regulatory deliverables for medical devices
Assisting in development of regulatory strategies
Assisting in preparation of US FDA submissions
Providing customers with documentation for international submissions
Creating/maintaining Technical Files
Reviewing product/manufacturing changes [Change Orders (COs)] for compliance with regulations
Reviewing protocols and reports to support regulatory submissions
Organizing regulatory information and track and control submissions
Reviewing product changes for impact on regulatory filings worldwide, license renewals, periodic updates and registrations to regulatory agencies
Researching regulatory issues and providing guidance and advice to colleagues
Representing Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process
Reviewing advertising and marketing material for appropriateness and compliance to regulatory requirements and laws
Keeping current on changing global regulations, product line and customer needs
Obtaining and maintaining GTIN numbers and GUDID Registrations
EDUCATION & CERTIFICATIONS
Bachelor’s Degree from a four-year College or University in a technical, engineering and/or scientific discipline. Professional designations are not required but training and certificates in regulatory affairs are a plus.
2+ years’ experience in a regulated Medical Device or Life Sciences industry with applied experience/knowledge in Regulatory Affairs.
Internal Number: RAS1
About Bovie Medical Corporation
Bovie Medical Corp. is a leading maker of medical devices and supplies as well as the developer of J-Plasma®, a patented plasma-based surgical product. J-Plasma® utilizes a gas ionization process that produces a stable, focused beam of ionized gas that provides surgeons with greater precision, minimal invasiveness and an absence of conductive currents through the patient during surgery. J-Plasma®, still in the early stages of commercialization, has the potential to be a transformational product for surgeons.
Bovie Medical is also a leader in the manufacture of a range of electrosurgical products and technologies. These are marketed through both private labels and Bovie’s own well-respected brands (Bovie®, Aaron®, IDS™ and ICON™) to distributors worldwide. The Company also leverages its expertise through original equipment manufacturing (OEM) agreements with other medical device manufacturers.