Hiring Now: Regulatory Affairs Specialist Near You – Apply Today!

Your Next Regulatory Affairs Specialist Job Starts Here – Apply Now!

Regulatory Affairs Specialist

Job Posted: 3 hours ago

Salary: £ 45,000 - 50,000 / Annum
Job Type: Permanent
Location: B61, Upper Marlbrook, Worcestershire

Expire in: a month

Job Description

Cure Talent are delighted to be partnered with an established medical device manufacturer with a long-standing portfolio of Class I and Class IIa medical devices supplied across the UK and European markets. Due to continued growth, they are now looking to appoint a Regulatory Affairs Specialist to join their Quality & Regulatory team based in Bromsgrove.

As the new Regulatory Affairs Specialist, you will play a key role in ensuring ongoing compliance with UK MDR and EU MDR requirements, supporting products throughout the full lifecycle from development through to post-market activities. Working closely with the QA Manager, you will be responsible for maintaining technical documentation, supporting regulatory submissions, liaising with regulatory bodies, and contributing to the continued development of the Quality Management System.

To be successful as the new Regulatory Affairs Specialist, you will have experience working within Regulatory Affairs in the medical device industry, with a strong understanding of UK MDR, EU MDR, UKCA and ISO 13485. You will have hands-on experience preparing technical documentation and supporting regulatory compliance activities within a regulated environment.

Key Responsibilities

  * Support the implementation and continual improvement of the Quality Management System in line with ISO 13485

  * Prepare, review and maintain Technical Files, Design Dossiers and GSPR checklists in accordance with UK MDR and EU MDR requirements

  * Support the preparation and maintenance of regulatory compliance documentation across the product portfolio

  * Prepare risk management documentation and Clinical Evaluation Reports

  * Coordinate Post Market Surveillance and Post Market Clinical Follow-up activities

Experience and Skills Required

  * Proven Regulatory Affairs experience within the medical device industry

  * Strong working knowledge of UK MDR, EU MDR 2017/745, UKCA and ISO 13485

  * Experience preparing and maintaining Technical Files and regulatory documentation

  * Experience supporting regulatory submissions and compliance activities

  * Experience working with Class I and Class IIa medical devices

  * Degree in Life Sciences, Engineering, Biomedical Science or a related discipline

If you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply now

Before You Apply

Do not include the following in your job application, CV, or cover letter:

Bank details.
National Insurance number.
Date of birth.

You should not be asked for payment or irrelevant information. If you have concerns about a job advert or employer, seek guidance on how to proceed.

Looking for your next career move? Join a top company hiring Regulatory Affairs Specialist job near me in B61, Upper Marlbrook, Worcestershire! This is your chance to work on exciting projects, grow professionally, and enjoy a rewarding career with competitive pay and excellent benefits. Whether you're an experienced professional or looking to take the next step, this role offers the perfect opportunity to enhance your skills and make an impact. Don’t miss out—apply today via Vita CV and take your career to the next level!