Regulatory Affairs Specialist

JR United Kingdom; Maidenhead; On-site; GBP 55,000 - 65,000; Full time

Job summary

A surgical instrument manufacturer in Maidenhead is seeking a Regulatory Affairs Specialist to join their team. This immediate vacancy offers a competitive salary up to £65,000, depending on experience, and provides opportunities for professional growth in a dynamic environment.

Qualifications

• Experience with Medical Device Regulations (MDR) is essential.
• Familiarity with ISO 13485 and MDSAP is required.
• Knowledge of CE Marking and FDA regulations is beneficial.

Responsibilities

• Ensure compliance with medical device regulations.
• Manage audits and regulatory submissions.
• Collaborate with internal teams for regulatory affairs.

Skills

Medical Device Regulations (MDR)

ISO 13485

MDSAP

CE Marking

FDA

Audits

Job description

Regulatory Affairs Specialist, Maidenhead

Client: Roc Search

Location: Maidenhead

Job Category: Other

EU work permit required: Yes

Job Views:

1

Posted:

25.05.2025

Expiry Date:

09.07.2025

Job Description:

Good Afternoon,

My client, a surgical instrument manufacturer based in Maidenhead, is seeking a Regulatory Affairs Specialist to join their growing team.

This is an immediate vacancy, and I am eager to hear from candidates interested in joining a fast-paced, forward-thinking company.

Desired experience includes:

• Medical Device Regulations (MDR)
• ISO 13485
• MDSAP
• CE Marking
• FDA
• Audits

This role is primarily onsite, with potential flexibility for remote work in the future. The position offers an attractive salary up to £65,000, depending on experience.

Please send an up-to-date CV if you're interested, and I will contact you promptly to discuss further.