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Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeAbout UsOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with a global presence across the US, APAC, and Europe. Our team comprises experts from various fields, including nanopore science, molecular biology, informatics, engineering, electronics, manufacturing, and commercialization. Our management...
Regulatory Affairs Specialist
2 months ago
Cure Talent is excited to partner with a leading Medical Devices Manufacturer, who due to continued growth, has an exciting opportunity for an experienced Regulatory Affairs Associate to join their team.
About the Role
The new Regulatory Affairs Associate will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring compliance with international regulatory requirements. This is a dynamic role where you'll collaborate with cross-functional teams to deliver new and existing products to market.
Key Responsibilities:
- Coordinate worldwide product registration submissions and ongoing maintenance.
- Facilitate new product registrations.
- Maintain Design Dossiers and Technical Files.
- Support regulatory activities related to change note approvals and complaint file reviews.
- Assist in delivering new and existing products in compliance with global regulatory standards.
Requirements
- Proven experience in a Regulatory Affairs role in Medical Devices.
- Knowledge and experience of Class III Medical Devices.
- Proven experience with technical file creation, maintenance and development
- Strong working knowledge and experience with ISO 13485
- Knowledge of Product Registrations, preferably Worldwide
What We Offer
Cure Talent is a leading recruitment agency specializing in the Medical Devices industry. We are committed to providing our clients with the best talent in the market. If you have the necessary skills and experience to be successful in this role, please get in touch with us today.
