Regulatory Affairs Specialist
Greater London, England, United Kingdom · À temps plein
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- Expérience
- N'importe lequel
- Salaire
- GBP 40,000 – GBP 50,000 / year
- Ouvertures
- 1
- Publié
- il y a 2 semaines
- Mode de travail
- Au bureau
- Admissibilité
- Individuals with proven Regulatory Affairs experience in the medical device industry are encouraged to apply.
- CV
- Candidature requise
Votre lieu de travail
Description de l'emploi
About the Role
Cure Talent is pleased to partner with a rapidly expanding medical device manufacturer that boasts a wide array of products in areas such as IV therapy, diabetes care, surgical, anaesthesia, and consumer health. Due to ongoing growth, they are seeking to recruit an additional Regulatory Affairs Specialist to join their Quality & Regulatory team. In this hands-on position, you will be instrumental in supporting the continuous development, upkeep, and implementation of regulatory activities throughout the company. You will gain exposure to the entire product lifecycle, collaborating closely with internal departments to ensure product compliance in various international markets and contributing to the definition of regulatory strategies.
Key Responsibilities
- Maintain and support the Quality Management System in accordance with ISO 13485 standards.
- Compile, examine, and update technical documentation for MDD, MDR, IVDR, UKCA, FDA, and procedure packs.
- Guarantee adherence to all relevant regulatory requirements and standards.
- Assist with document control processes, including procedures, labeling, and product documentation.
- Play a role in the implementation of Unique Device Identification (UDI) and product lifecycle management.
- Organize and provide support for both internal and external audits.
- Track regulatory changes and facilitate their implementation across the organization.
Experience and Skills Required
- Demonstrated experience in Regulatory Affairs within the medical device sector.
- Proven ability to support regulatory strategy and submission processes.
- Familiarity with MDR and FDA regulatory frameworks.
- Solid understanding of ISO 13485.
- Experience managing technical documentation and regulatory files.
- Excellent organizational abilities with a keen eye for detail.
- Capacity to collaborate effectively across departments in a regulated setting.
Additional Information
Job type: Permanent
County: Greater London
Country: United Kingdom
Job ref: CT2050
Post Date: 01-05-2026 04:49 PM