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Senior Regulatory Specialist

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Cardiff, United Kingdom Frontier Medical Group Full time

Are you a Regulatory Specialist looking for a stimulating role in the medical device industry? Join our team and take charge of regulatory affairs as a Senior Regulatory Specialist. With a competitive salary, you'll play a pivotal role in ensuring compliance and guiding NPD projects through regulatory hurdles. Your responsibilities will include developing and implementing regulatory strategies, maintaining compliance of products, preparing regulatory submissions, and liaising with international regulatory authorities. If you possess strong leadership skills, effective communication abilities, and a drive for project completion, alongside a commitment to professionalism and continuous improvement, we invite you to be part of our dedicated team revolutionizing medical technology


At this time, we kindly request that agencies refrain from contacting us regarding this opportunity. We are currently managing our recruitment process internally and appreciate your cooperation in respecting our preferences.

_________


Job Title: Senior Regulatory Specialist

Location: Office based (either Cardiff or Tredegar, depending on location)

Hours of work: Monday to Friday 09.00-17.00

Responsible to: R&D Manager


Main purpose of job:

Provide leadership on regulatory affairs, supporting NPD projects, maintain compliance of products, support audits, owning risk management file and CER, developing and implementing RA strategy, product surveillance, preparation of tech file, submission of regulatory applications and communications with international regulatory approvals. Be part of the NPD team, reviewing and approving documents, involve in design and stage gate reviews. Surveillance of new standards and ensuring NPD meets recognise consensus standards, etc. Involve in CAPA team to resolve issues.


Qualifications required:

BEng/BSc in Engineering or Science or related field with RA experience in medical device industry. BEng/BSc in mechanical/medical/biomedical/materials engineering is an advantage.


Experience required:

RA experience in Class 1 medical device as essential (Class 2 will be desired) for major territories FDA, UKCA and MDR is essential. Additional knowledge for Canada, Australia, Japan registration will be desired.


Main duties:

  • Design and implement QMS for design control, be part of NPD team and remediation activities to prepare and maintain tech files to ensure continuous compliance. Good knowledge of ISO13485 and ISO14791 and maintenance of RMF.
  • Timely preparation of submissions and communication with regulatory organisations such as Q-sub and eSTAR with FDA, etc.
  • Develop and implement regulatory strategy for NPD and existing products to maintain compliance.


Essential skills:

  • Able to lead RA activities and be the first point of contact for compliance enquiries.
  • Good communication skills and can effectively communicate with regulatory, legal, R&D, sustaining engineering, sales and operations.
  • Able to work with NPD teams.
  • Computer skills
  • Able to manage day-to-day activities and tasks, and work independently in RA matters


Key personal attributes:

  • “Can do” attitude; A “finisher” and drive to complete projects, with a track record of products from start to launch
  • Honesty and integrity
  • Dependability and reliability
  • Flexibility and willingness to work collaboratively
  • Emotional intelligence and creativity
  • Committed to professionalism and continuous improvement and personal development
  • Must have a positive & optimistic attitude, very responsive and helpful always
  • Customer and patient focus – safety and usability
  • Team player - working as part of a close-knit team


Other desirable skills / experience:

  • Class 2A/B medical device experience
  • Good regulatory application knowledge on other territories in addition to FDA/UKCA/MDR
  • Clinical knowledge in tissue viability is desirable


Employment checks:

  • Checks will be carried out on right to work in the UK where appropriate