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 Regulatory Specialist to join a growing team in Raleigh Durham, North Carolina. This temp to direct position offers growth and a great benefit program.
- Plan, compile, prepare, and submit applications to register new, and re-register existing, company products with global regulatory agencies.
- Facilitate all administrative and technical phases of regulatory submission, including coordination of legalization activities of registration documents, photocopying, paginating, reviewing, and proof-reading.
- Review product and process changes to determine impact to existing product licenses and prepare necessary supplements/amendments/notifications to ensure compliance with market requirements.
- Coordinate sales and supply chain efforts to ensure compliance with registration and distribution requirements for new market launches and to minimize supply disruptions during change management of assigned product lines.
- Work effectively in a team environment, facilitating communication with both internal and external partners, and monitoring progress against the project plan.
- Provide guidance and support to management and corporate personnel regarding regulatory issues and related initiatives.
- BS/BA, in regulatory affairs, engineering, life sciences or related discipline
- Must possess highly effective written and verbal communication skills.
- Must be detail-oriented and possess considerable organization skills.
- Ability to prioritize work and manage multiple projects under budget and time constraints.
- Ability to effectively partner with employees, management, department and cross-functional teams to meet performance objectives and to support mission and vision of the Company.
- Relevant computer software experience
- Minimum 3 years of experience with US and/or international medical product registrations experience.
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”.