Regulatory Affairs Specialist / RA Specialist

Posted 8 November by Quay Recruitment Groups Limited
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Regulatory Affairs Specialist - West Sussex £40,000 - £45,000

Are you an experienced regulatory affair professional within medical devices?

Have you knowledge of ISO 13485 and the MDD/MDR?

This is an excellent opportunity to join a leading medical device company who are leaders within their field.

Roles and responsibilities:

The Regulatory Affairs Specialist will have the following duties:

  • Developing registration and launch plans with the regional sales managers to ensure that
  • The preparation and submission of registration dossiers, and their submission and
  • Establish and maintain regulatory information systems such as technical documentation, quality records, routine reports and regulatory agency communications
  • Ensure compliance to global regulatory requirements and company policies
  • Review document and product changes for regulatory submission impact
  • Interface and co-ordinate with regulatory agencies; provide regulatory input and appropriate follow-up support to inspections and audits (e.g. FDA, Notified Bodies etc)

Requirements:

As Regulatory Affairs Specialist, you will ideally have the following skills, experience and knowledge:

  • 2-3 years' experience in a regulatory role within medical devices
  • A degree or formal qualification within a scientific or suitable subject
  • Experience with ISO 13485 and CFR
  • Knowledge of registrations for the following countries would be desirable - India, China, Russia, Brazil and USA

The package:

The successful candidate for the role of Regulatory Affairs Specialist will receive the following:

  • Salary - £40,000 - £45,000 (could be negotiable for someone with exceptional experience)
  • Company pension
  • Excellent working environment and career prospects

This role is commutable from Crawley, Brighton, Worthing, Chichester, Horsham

Keywords: Regulatory affairs, RA Specialist, RA Analyst, Regulatory affairs analyst

Required skills

  • MDR
  • medical devices
  • RA
  • MDD
  • pharmaceuticals
  • regulatory affairs

Reference: 39329379

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