Senior Regulatory Affairs Associate
4 weeks ago
Cure Talent are delighted to be working with a global Medical Device company that design, develop and manufacture innovative Medical Devices to create better patient outcomes. Due to their continued growth and success, we have an exciting opportunity for a Senior Regulatory Affairs Associate to join them in North Yorkshire.
As the new Senior Regulatory Affairs Associate, you will be part of an experienced team of Regulatory & Quality professionals responsible for creating Technical Files for new and existing products, product submissions, regulatory compliance and working closely with R&D for NPD.
To be successful in this role, you will be a degree educated professional with a proven background within Regulatory Affairs within the Medical Device sector. Technical knowledge and experience should encompass technical file creation & development, device submissions within the UK & EU.
Key Role Responsibilities
- Technical File and DMR Creation for new and existing products
- Product Submissions for UK & EU, FDA experience is a bonus
- Regulatory Compliance
- Work closely with R&D on NPD
Required Skills, Experience & Education
- Degree educated in a relevant discipline
- Proven experience in the Medical Device Sector within a RA role with Class 1, 2a & 2b devices
- Experience of Technical File creation
- Product Registrations
If this sounds like you and you’re looking to join an established, yet growing company at the forefront of creating better patient outcomes, get in touch with Kris Holmes at Cure Talent today
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