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Regulatory specialist

Sheffield
Medibeam
Posted: 6h ago
Offer description

Regulatory Affairs Specialist


Medibeam are hiring for a Regulatory Specialist to join a well known Medical Device manufacturer.


The last regulatory hire here went from grad to senior within 3 years.

This company don’t sleep on progression, they want people to succeed and grow in their role.


If you’re stagnated in your current role and craving more, this position will have you touching on every element of Regulatory Affairs, with a strong team and management support, so you don’t feel alone in decisions.


Please note, this client can only consider people with the right to work in the UK and do not have the ability to offer sponsorship.


What You’ll Do:

* Own and maintain Technical Files and Design Dossiers, ensuring compliance with evolving EU and international standards.
* Liaise with Notified Bodies and regulatory agencies to drive successful submissions.
* Support global market entry into new countries
* Monitor post-market surveillance data and ensure risk documentation is up to date.


You’ll Thrive Here If You:

* Want real ownership, not just delegated tasks.
* Understand medical device regulations (especially MDD/MDR) and enjoy navigating global requirements.
* Enjoy autonomy, but value collaboration across RA, QA, Engineering, and Marketing teams.


What You Bring:

* A degree (or equivalent experience) in life sciences or engineering.
* Strong understanding of medical device regulations, CE marking, and technical documentation.
* Experience managing submissions and updates for international market access.


Ideally, you will have 1-2 years of experience working within a Regulatory Affairs role and have exposure working across technical documentation.


How to apply: Apply today or email amy@medibeam-search.com to learn more about the role.


Also connect with me on LinkedIn to hear about regular job updates available with Medibeam.

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