Regulatory Specialist - London, United Kingdom - ProClinical

ProClinical
ProClinical
Verified Company
London, United Kingdom

1 month ago

Tom O´Connor

Posted by:

Tom O´Connor

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Description

Salary:

Highly Competitive


Job type:

ContractDiscipline:

Consultant / Specialist
Location:
United Kingdom- City of London, England

  • Posting date: 18 Apr 2024

Reference:
59986

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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