Medical Device Regulatory Expert

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Medical Device Regulatory Expert, Samarate

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Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

898430327800725504033710

Job Views:

2

Posted:

02.07.2025

Expiry Date:

16.08.2025

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Job Description:

We are seeking a Regulatory Compliance Specialist to join our team and support global registrations of medical lasers, optical fibers, and related accessories. This role will ensure compliance with regulatory requirements and standards.

• Key responsibilities include contributing to international registrations, defining regulatory strategies, preparing documentation and application dossiers, liaising with regulatory authorities and partners, and supporting review processes by addressing reviewer questions and closing gaps.
• This position also involves managing post-approval activities such as design changes, product configuration updates, license archiving, and preparing communications for international authorities to maintain registrations.

Candidates should have a degree in scientific disciplines, at least 3 years of regulatory affairs experience (preferably in medical devices), fluency in English and Italian, and the ability to work effectively both independently and within a team.

Required skills include experience in drafting technical files, knowledge of medical device regulations (MDD, MDR, 21 CFR 803-806-820, 21 CFR Ch. I Subpart J, MDSAP, ISO 13485), familiarity with ISO 10993 and ISO 14971 standards, and experience with IEC standards (IEC 60601 series, IEC 62304, IEC 62366). Experience with complaint evaluation and assessing regulatory impacts of design changes is also necessary.

This role offers opportunities to develop electronic document management systems, evaluate the regulatory impact of design changes, and manage notifications and license amendments with certification and regulatory bodies.