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Job Information

Regulatory Affairs Specialist

Information About this Role

Job Summary

Job Title: Regulatory Affairs Officer

Location: West Sussex

Industry: Medical Devices and Healthcare

Salary: 30-40K (Dependant on experience) plus pension and excellent benefits.

Shortlisting Wednesday 14th October

Company Description

We've got an exciting opportunity for a degree educated Regulatory Affairs Officer professional at a hugely successful Medical Device company who are renowned within their specialist niche. The company are about to embark on a new phase of growth after key investment in research and development for an exciting new range of products and an existing range of products.

Accordingly, our client are seeking a new Regulatory Affairs Officer to play a dynamic role in working alongside the RAQA Manager to ensure on compliance for their products across international markets and local regulations.

This is a great opportunity to work within a dynamic environment, receiving great career development and enjoying a lead contribution to the ongoing success of the department and its integral role within the whole company.

Job Description

To support the regulatory affairs objectives in the maintenance and development of Regulatory Affairs systems and to assist with compliance of product and activities with the Medical Device Directive 93/42/EEC; 21 CFR Part 820; BS EN ISO 13485:2012.

To support in the creation and on-going management of technical files, design history files and FDA 510K submissions.

Key Responsibilities

  • COMPLIANCE: Assistance in compliance with MDD 93/42/EEC Medical Devices Directive, FDA and CMD Regulations. Compliance with the WEEE and RoHS Directives.
  • AUDITS: Assistance with third party audits from Notified Bodies and Regulatory Authorities as well as internal audits as necessary.
  • VIGILANCE: reporting, liaison with Competent Authorities, Notified Bodies, distributors, customers and internal departments regarding vigilance and reportable incidents.
  • TECHNICAL FILES: Compiling, submitting and supporting technical files and 510(k) submissions.
  • UP-TO-DATE SYSTEM: keep up to date with latest regulatory developments and training
  • DOCUMENT CONTROL: Maintaining regulatory documentation in a logical system with easy access in audit situations
  • DISTRIBUTORS: Compiling documentation for distributors relating to international registrations
  • STERILISATON: Assist in the annual review of sterilisation parameters and management of packaging validations.
  • CLEANROOMS: Regulatory compliance and maintenance of the cleanroom environment in accordance with BS EN ISO 14644
  • CROSS FUNCTION: Working as regulatory representative and/or lead on R&D and manufacturing projects in accordance with required standards including EN 60601-1/2, EN 62304

Experience and Skills Required for the Regulatory Affairs Officer

  • Degree level in engineering or scientific academic discipline
  • 3 years' experience in regulation of class II/III medical devices
  • Excellent knowledge of MDD, ISO 13485 and ISO 14971
  • Preferably good knowledge of one or more of the following:
    • MEDDEVs and other guidance documentation
    • ISO 62304
    • ISO 60601
    • ISO 10993
    • ISO 11135
  • Experience of working with international distributors
  • PMS and vigilance management
  • Sterilisation validation
  • Excellent problem-solving communication, and organisational skills
  • Excellent written English and report writing ability

Sound like you? Apply NOW! Don't miss out on this exciting opportunity as a Regulatory Affairs Officer.

If you have any further queries regarding this role please call James Powell on: 0203 8000509

Projectus Consulting

Projectus Consulting are a leading Medical Device Recruitment Consultancy. We're a niche business who provide a highly specialist service to both employers and candidates in the Medical Technology Sector.

We are dedicated to finding the right opportunity for you.



Twitter: @projectusjobs