Regulatory Affairs Senior Associate

TN United Kingdom; Manchester; On-site; GBP 40,000 - 70,000; Full time

Job summary

An exciting opportunity awaits in the Regulatory Affairs sector with a market-leading medical devices company. This role as a Senior Associate involves ensuring that supply chain operations comply with all relevant quality legislation, creating and updating technical files, and responding to regulatory inquiries. If you have a passion for regulatory affairs and a keen eye for detail, this position offers a chance to grow your career while contributing to innovative healthcare solutions. With the potential for hybrid work after probation, this role provides flexibility and a dynamic work environment.

Qualifications

• 2-5 years of experience in Regulatory Affairs, especially in medical devices.
• Knowledge of ISO 13485 and MDD/MDR regulations.

Responsibilities

• Ensure compliance with quality legislation in supply chain operations.
• Create and review technical files for Class I-IIb Medical Devices.

Skills

Regulatory Affairs

ISO 13485

Medical Device Regulations

Attention to Detail

Job description

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Regulatory Affairs Senior Associate, Manchester

Client:

Carrot Recruitment

Location:

Manchester, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

0c0da216c84a

Job Views:

5

Posted:

05.05.2025

Expiry Date:

19.06.2025

Job Description:

The Role

This is an exciting opportunity for someone to develop their career in Regulatory Affairs within a market-leading medical devices company. You’ll be responsible for ensuring supply chain operations comply with all relevant quality legislation.

Creating, updating, and reviewing technical files for Class I-IIb Medical Devices.

Responding to regulatory enquiries, both internally and externally.

Assisting the RA Manager and RA/QA Consultant with regulatory tasks.

You

To apply for this role as Regulatory Affairs Senior Associate, the client is looking for someone with the following skills and experience:

• Ample experience in Regulatory Affairs, specifically within medical devices (2-5 years ideally).
• Full lifecycle RA experience is preferred, but experience with pre- or post-approval stages will also be considered.
• Knowledge of ISO 13485, MDD, MDR.
• Excellent attention to detail.
• Located within a commutable distance to West Yorkshire, as this role will initially be onsite with potential for hybrid work after passing probation.