Senior Regulatory Affairs Specialist

Jonathan Lee Recruitment Product Eng
£50k pa
06 Oct 2017
02 Nov 2017
Contract Type
Full Time

My client are a British owned medical device manufacturer based in the Birmingham area. They are experiencing strong growth and export to a variety of international markets. They are seeking an experienced Senior Regulatory Affairs Specialist.

Role purpose

Accountable for ensuring the company and products meet the standards required for continued regulatory compliance.

Accountable for ensuring post market activities are carried out in line with relevant regulatory requirements. Ensure the appropriate licensing and legal compliance of the company's medical products and other activities.

Main Responsibilities

  • Involvement in, and maintaining an appropriate and effective regulatory strategy to achieve compliance
  • Produce and review the technical and regulatory documentation in accordance with ISO 13485 and regulatory requirements in line with continuous improvement programmes and/or changes required through standards.
  • Investigate, remediate and successfully conclude all regulatory issues that are product related.
  • Manage process for formal discontinuation of product
  • Maintain a keen awareness of customer requirements, applications and manner of use (e.g. attendance at in-house training sessions).
  • Participate, when required, in company/ divisional/ functional meetings.
  • Support the regulatory team in processing global product registrations and approvals for chosen markets
  • Support Risk Management activities
  • Understand and apply quality assurance procedures in line with ISO 13485:2016 quality management system standards, the Medical Devices Directive 93/42/EEC (as amended) and Medical Device Regulation MDR 2017/745.
  • Ensure the company has up-to-date intelligence relating to upcoming changes that impact compliance.
  • Ensure personal compliance with internal regulatory, quality and other procedures.
  • Ensure the company is compliant to global regulatory requirements for quality systems and product registrations / approvals including CMDCAS.
  • Conduct training, where necessary of company personnel who interact with the Regulatory Department regarding new regulations and policies that could impact the company's products or processes.

Experience Required

  • Minimum 5 years experience in Regulatory Affairs within the Medical Device industry (MDD)
  • Broad knowledge of post market activities
  • Broad knowledge of quality systems and procedures
  • Broad knowledge of global medical device regulations and international standards
  • PHARMA Responsible Person (not essential)

To be considered for this attractive Senior Regulatory Affairs Specialist role please apply as soon as possible.

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