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RA Specialist

Job Posted: 11 days ago

Salary: £ 40,000 - 50,000 / Annum
Job Type: Permanent
Location: Oxford, Oxfordshire

Expire in: 17 days

Job Description

Are you an experienced regulatory professional looking for your next long-term career move?
I am partnering with an innovative, medical technology business to find a dedicated Regulatory Affairs Specialist to join their growing RAQA team on a permanent & 100% remote basis!
In this pivotal role, you will champion global regulatory compliance, drive regulatory strategy, and ensure seamless market access for cutting-edge products across multiple regions.
What You Will Be Doing:
  * Leading and managing critical regulatory submissions, with a primary focus on EU MDR technical files and FDA 510(k).
  * Acting as the Person Responsible for Regulatory Compliance (PRRC) when required.
  * Producing and maintaining essential clinical (CEP, CER) and post-market surveillance (PMSP, PSUR) documentation.
  * Guiding cross-functional Product and Engineering teams to embed regulatory requirements directly into the product development lifecycle.
  * Managing vigilance activities and driving new regional product registrations.
What You Bring to the Table:
  * A solid regulatory affairs background within the medical device sector.
  * Proven, hands-on success with EU MDR and FDA 510(k) submissions.
  * Deep working knowledge of ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, and ISO (phone number removed).
  * A relevant degree in Life Sciences, Biomedical Engineering, Computer Science, or RA.
  * Direct experience with Software as a Medical Device (SaMD) and an understanding of medical imaging modalities!
If you are ready to take ownership of global regulatory strategies in a forward-thinking, collaborative environment, let’s talk

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Looking for your next career move? Join a top company hiring RA Specialist job near me in Oxford, Oxfordshire! 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!