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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