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Job type: Contract

Discipline: Consultant / Specialist

Location: United Kingdom

IVD Regulatory Affairs Specialist | Remote | EU

Proclinical are seeking a dedicated professional to lead regulatory affairs in the in-vitro diagnostics sector within the EU for a Regulatory Specialist role which is a remote position.

Responsibilities:

- Independently assemble and maintain technical and regulatory documentation for EU Annex XIV and local Ethics Committee submissions.
- Lead in addressing and responding to deficiencies.
- Maintain regulatory paper and electronic files.

Requirements:

- BS Degree in Sciences, Engineering, or similar discipline with 5+ years of experience in regulatory affairs in the medical device industry.
- Demonstrated knowledge and understanding of global medical device regulations, including EU, Switzerland, and UK.
- Proficiency in English, both written and spoken, with strong interpersonal communication skills and attention to detail.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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