Senior RA Spec - new job in Crewe, UK

Senior RA Spec
  • £45,000 - £55,000 per Annum
  • Permanent
  • Crewe, Cheshire, England, UK Crewe Cheshire UK CW1 6GL
Job Ref: J2165518
Sector: Engineering
Sub-sectors: Biotech/Life Sciences, Medical Devices
Date Added: 23 June 2022
Global, innovative medical device company looking for Senior Regulatory Affairs Specialist

Here at SRG, we are honoured to be working with a thriving, innovative medical device company. Operating on a global scale, they specialise in wound care, trauma, and hemostats, with over 20 products across the business. They are looking for a Senior Regulatory Affairs Specialist to join their site based in Crewe.

As the Regulatory Affairs Associate, you will be responsible for providing regulatory expertise in the research, development, and marketing of products to ensure that regulatory approvals are obtained and maintained in accordance with agreed company objectives. Some of your main duties and responsibilities will include:

  • To provide ongoing regulatory advice to project teams throughout the product and process development to ensure regulatory concerns are planned and accounted for and the relevant data is generated to meet regulatory/project objectives
  • In relation to the above, to interpret individual country legislation relevant to the business units
  • To compile, review approve regulatory submissions in accordance with national requirements to ensure appropriateness and consistency in content
  • To compile and maintain regulatory strategy documentation
  • To complete the requirements of the global registration plan in line with business unit needs
  • To provide advice/guidance in an expert capacity to other members of the RA team
  • To liaise with external regulatory authorities to ensure approvals are obtained in line with business plans
  • To review and approve design change/change control assessments
  • To review and approve artwork, labelling and promotional material and advise on its acceptability/compliance with regulations and registered details
  • Maintain up-to-date knowledge of regulatory legislation and guidelines.
  • Create and maintain Technical Files and documents in line with regulatory requirements.
  • Deputise for the Regulatory Affairs Manager, where appropriate and when required
  • To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485
  • To apply standards of occupational Health and Safety in the workplace and comply with company policy and procedures

As the ideal candidate, you will be educated to degree level or higher in a relevant scientific discipline and have at least 3 years' experience working within a regulatory roles for medical device industry. Knowledge of FDA Quality System Regulation, ISO 13485 and the MDD to MDR transition are essential. Knowledge of 510(k) submissions and ISO 14971 would be advantageous. Experience of Medical Device registration in global markets including Canada, Brazil, Australia, Middle East, and Far East would be an advantage.

23/07/2022 12:58:21
GBP 45000.00 55000.00 Annum

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