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Senior Regulatory Specialist
Job Posted: 7 days ago
Salary: £ 60,000 - 70,000 / Annum
Job Type: Permanent
Location: Cambridge, Cambridgeshire
Expire in: 21 days
Job Description
A growing MedTech company is seeking an experienced Senior/Lead Regulatory Affairs Specialist. The ideal candidate will act as the key liaison between the business, its products, and regulatory bodies, with responsibility across pre- and post-market regulatory activities.
We’re looking for someone with practical experience in Medical Technology (Wearables, Monitoring, Software as a Medical Device) quality and regulatory frameworks (including FDA submissions and international standards) who can guide products from development through to market launch and beyond.
Key responsibilities:
* Provide regulatory guidance to internal teams and senior management, supporting the preparation and submission of regulatory documentation.
* Maintain and update regulatory files and tracking systems to ensure timely access to approval and renewal information.
* Ensure products comply with regional and international regulations and standards.
* Keep abreast of evolving legislation, guidelines and industry practices.
* Analyse and present scientific data to support new product approvals and renewals.
* Manage submission timelines for licence variations and renewals, ensuring deadlines are met.
* Prepare and review product labels, patient information leaflets and related documentation.
* Advise on product testing requirements and interpret clinical and technical data.
* Offer strategic regulatory input during product development and updates.
* Lead or coordinate regulatory inspections and audits.
* Liaise and negotiate with regulatory authorities to secure product authorisations.
* Support process improvements and provide compliance training and advice to teams.
About You:
* Experience working within Medical Technology in a regulated environment, ideally including FDA 510(k) submissions and relevant international standards.
* Strong industry experience operating in a Senior/Lead level role within Regulatory Affairs.
* Proven ability to manage regulatory processes, from documentation through to communication with authorities.
* Strong analytical skills and the ability to clearly communicate complex technical and regulatory concepts.
* Collaborative, organised and able to manage multiple projects and deadlines.
If this role looks like your next challenge, please contact Ben ASAP or apply via this advert!
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