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Regulatory Affairs Manager

Job Posted: 2 days ago

Salary: £ 65,000 - 65,000 / Annum
Job Type: Permanent
Location: High Wycombe

Expire in: a month

Job Description

The next step in your career doesn't have to mean leaving the technical work behind. As a Regulatory Affairs Manager, you'll use your medical device expertise to guide important decisions, support colleagues and turn complex requirements into practical actions that keep products compliant and moving into international markets. 

 This is a genuine step-up opportunity for someone already mentoring others, leading projects or becoming the person colleagues turn to for regulatory guidance. You'll remain close to products and submissions while gaining greater influence across compliance, product development and market access. 

 What’s in it for you

c£65,000 salary plus bonus.
A genuine opportunity to progress from a senior specialist-level position into leadership.
The chance to retain hands-on technical involvement while developing your ability to lead and support others.
Broad exposure across product development, compliance, submissions and international market access.
The opportunity to influence decisions across Engineering, Operations, Quality, Production and Commercial teams.
Scope to help shape how requirements are understood and applied across the wider business.
Your responsibilities as Regulatory Affairs Manager

Interpret complex medical device regulations and translate them into clear, practical actions for the wider business.
Support technical documentation, regulatory submissions and ongoing compliance activities.
Work with Notified Bodies and support regulatory audits and inspections.
Provide guidance across Engineering, Operations, Quality, Production and Commercial functions.
Support activities across international markets, helping teams understand and meet relevant requirements.
Coach and mentor less experienced colleagues while contributing to cross-functional decisions.
What we’re looking for in a Regulatory Affairs Manager

Strong Medical Device Regulatory Affairs experience, including practical knowledge of EU MDR.
Experience supporting medical device technical documentation and submissions.
Exposure to Notified Bodies, audits and regulatory inspections.
Strong technical writing skills and experience interpreting regulatory requirements for practical application.
Experience supporting activities across international markets and working with multiple business functions.
If you're already taking the lead on complex challenges and are ready to make that progression official, apply now for this Regulatory Affairs Manager opportunity.

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