Regulatory Specialist and Senior Specialist
3 weken geleden
This Senior RA Specialist will oversee regulatory activities across two manufacturing sites (separate legal entities) in Germany and the Netherlands, managing a portfolio of Class IIa, Class I, and Class S (non-sterile and sterile) medical devices. Reporting to a manager within the EMEA RA department, the successful candidate will be the primary RA contact for these sites and will act as the Person Responsible for Regulatory Compliance (PRRC), taking responsibility for documentation and compliance with MDR, ISO 13485, and sterilization standards.
Develop and implement regulatory strategies for medical devices.
Manage product registrations within EMEA, with potential for broader regional responsibility.
Provide RA guidance and support to internal teams.
Maintain relationships with external stakeholders on quality and regulatory issues.
Act as PRRC, ensuring regulatory compliance and documentation.
Bachelor's degree in a scientific or technical field (biomedical or pharmaceutical preferred).
~4-6 years of experience in medical device regulatory affairs.
~ Proven experience with technical file management.
~ Fluency in English (Dutch language skills are a plus).
~ Ability to work independently and manage multiple projects.
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