Are you looking for an opportunity where you can be part of a growing industry? Well regarded company in the Medical Device industry needs a dynamic Senior Regulatory Specialist to join a growing team in Raleigh Durham, North Carolina. This position offers growth and a great benefit program.
Senior Regulatory Specialist
- Plan, compile, prepare, and submit applications (510(k), PMA, Technical Documentation, etc.) to register new, and re-register existing, company products with global regulatory agencies
- Communicate with FDA and other regulatory bodies regarding submissions.
- Review and approve design, manufacturing and labeling changes to ensure compliance with FDA and international government regulations. Prepare necessary supplement/amendment/notification for changes
- Facilitate/perform all administrative and technical phases of regulatory submission, including coordination of legalization of activities of registration documents, scanning, formatting, compiling, quality control and proof-reading
- Represent the regulatory function on manufacturing and development teams as the subject matter expert to develop regulatory strategies
- Review test protocols and reports, labeling, risk management, design control and other documentation for assigned product lines to ensure all documentation is prepared accurately and in a manner that facilitates approval to meet the company's product launch timelines in all markets
- Working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements
- Provide strategic direction and coordinate sales and supply chain efforts to ensure compliance with registration and distribution requirements, while also minimizing supply disruptions in relation to changes management of assigned products.
- BS/BA in regulatory affairs, engineering, life sciences or related discipline
- Must posses highly effective written and verbal communication skills
- Working knowledge of design controls, risk management, CGMPs, etc.
- Experience with implantable medical devices is high desirable
- Knowledge of human tissue regulations
- Ability to prioritize work and manage multiple projects under budget and time constraints
- Be able to effectively partner with employees, management, department and cross-functional teams to meet performance objectives
- Relevant computer software experience (MS Word, Excel, PowerPoint, Visio, Adobe Pro)
- Minimum 5 years of experience with US and/or international medical product registrations.
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace. We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be. Apply today and experience “The DAVIS Difference”.