Regulatory Affairs
Regulatory Affairs Specialist
Summary
The Regulatory Affairs Specialist will prepare and submit country-specific documentation to obtain and maintain medical device market clearances, while supporting regulatory processes and working with project teams, customers, and authorities.
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Opportunity summary
Koch Home Page Your Job Are you interested in being part of a team responsible for registration of medical devices worldwide? Are you interested in working in a challenging regulatory environment at the interface between device and drug regulations, and willing to expand your regulatory expertise?
Then you may be the person we are looking for to join our growing team in Phillips-Medisize’s Global Innovation & Development Center based in Struer and Virum. What You Will Do - Maintain a deep understanding of country-specific regulatory requirements. - Execute regulatory strategy by generating country-specific regulatory documentation.
- Work in close cooperation with the project managers, engineers, and regulatory team. - Identify and interface with local representatives worldwide. - Review and ensure compliance of the technical documentation. - Assemble regulatory submission packages.
- Submit required documentation to gain market clearance. - Interact with customers and regulatory authorities to ensure regulatory clearance. - Support development and improvement of the regulatory affairs & submission process. - Maintain market clearance and assess change impact on approval status.
- Participate in audits from authorities, customers and notified bodies Who You Are (Basic Qualifications) - Bachelor’s degree in life science, engineering or equivalent1 …
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