Job description


  • Entry level
  • No Education
  • Salary to negotiate
  • Shoreham-by-Sea


Senior Regulatory Affairs Specialist

Our client is a well-established manufacturer working in the Medical Devices sector, this company has been established within in its market for a long time and is currently launching multiple new products year on year.

Working as part of the regulatory team, this is a fantastic opportunity for an individual with a good level of previous regulatory affairs experience working in the medical device industry to enhance their career as a Senior Regulatory Affairs Specialist and improve the vision of millions of patients worldwide through the development of innovative new products.

Key responsibilities:

* Regulatory system establishment and maintenance

* To be up to date with changing regulatory requirements and guidelines

* Document reviews

* Collating documents for submission, submission and life cycle maintenance of the existing products

* Supporting internal and external audits

* Co-operatively working with other departments to ensure regulatory requirements and processes

Skills and experience:

* Science, engineering or relevant clinical degree

* 3-5 years RA medical device experience

* 13485, and/or CFR 820, MDSAP

* MDR experience

* Registration experience to at least one of the following countries are desirable but not essential: USA, Brazil, Russia, China, India

* Familiar with databases and management systems

Key competencies:

* Excellent communication skills (verbal, written and listening)

* Integrity and openness

* Personal drive and confidence

* Adaptability and team work

Contact: Aniko Ruff

Keywords: Regulatory, Regulatory Affairs, Reg affairs, med devices, medical devices, ISO13485, 13485, CFR820, MDSAP, standards, compliance, FDA, Notified Bodies
Role: Senior Regulatory Affairs Specialist
Job Type: Permanent
Location: Shoreham-by-Sea, West Sussex,

Apply for this job now.

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