Cure Talent
Principal Regulatory Affairs Specialist
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Principal Regulatory Affairs Specialist
Principal Regulatory Affairs Specialist
About the Role
Cure Talent are delighted to announce a partnership with a global medical device organisation, recognised as one of the most established and successful healthcare companies in the world. This business maintains a strong international presence and invests in next-generation technologies, expanding its regulatory capabilities across high-profile product programmes.
We are seeking a Principal Regulatory Affairs Specialist to join their team and support the development and MDR 2017/745 approval of a brand-new medical device programme. This role will focus on technical Regulatory Affairs ownership and cross-functional project leadership, rather than people management.
The role involves close collaboration with R&D, Clinical Affairs, and global Regulatory Teams throughout the product development lifecycle, from early-stage development to submission and approval. The successful candidate will contribute to the regulatory strategy of the programme, defining approval pathways, managing regulatory risk, and engaging with Notified Bodies and Competent Authorities.
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Key Responsibilities
- Support the development and approval activities for a new medical device programme under MDR 2017/745.
- Work collaboratively with global Regulatory Affairs, Clinical Affairs, and R&D teams across the product development lifecycle.
- Contribute to regulatory strategy activities and define EU approval pathways.
- Develop and maintain regulatory plans aligned with product development and submission milestones.
- Provide regulatory input into:
- Technical documentation
- Risk management
- Clinical activities
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Requirements
Experience and Skills
- Proven Regulatory Affairs experience within the Medical Device sector.
- Strong working knowledge of MDR 2017/745 and associated regulatory frameworks.
- Experience supporting regulatory activities for medical device development programmes.
- Experience contributing to:
- Regulatory submissions
- Technical documentation activities
- Experience with Class III medical devices, combination products, or drug-device products would be advantageous but is not essential.
- Degree-qualified in a scientific, engineering, or related discipline.
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