Regulatory Affairs Specialist

3 weeks ago

Tredegar, Blaenau Gwent, United Kingdom Recruitment Solutions Workforce Ltd Full time
Senior Regulatory Specialist - Medical Device

Location: Cardiff/Tredegar

Type: Permanent Full Time

Salary: £40K - £50K PLUS BENEFITS

We are seeking a meticulous Regulatory Specialist to join our Clients' team. The successful candidate will play a crucial role in ensuring compliance with regulatory requirements within our Clients' organisation.

Main Purpose of Job:

Provide leadership on regulatory affairs, supporting NPD projects, maintaining compliance of products, supporting audits, owning risk management file and CER, developing and implementing RA strategy, product surveillance, preparation of technical files, submission of regulatory applications, and communications with international regulatory approvals.

Key Responsibilities:
  1. At least 4 years RA experience in Class 1 medical device as essential (Class 2 will be desired) for major territories FDA, UKCA, and MDR is essential.
  2. 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.
  3. Timely preparation of submissions and communication with regulatory organisations such as Q-sub and eSTAR with FDA.
  4. Develop and implement regulatory strategy for NPD and existing products to maintain compliance.
Requirements:
  1. Able to lead RA activities and be the first point of contact for compliance enquiries.
  2. Good communication skills and can effectively communicate with regulatory, legal, R&D, sustaining engineering, sales, and operations.
  3. Computer skills.
  4. Emotional intelligence and creativity.
  5. Committed to professionalism and continuous improvement and personal development.

Preferred qualifications include Class 2A/B medical device experience and good regulatory application knowledge on other territories in addition to FDA/UKCA/MDR.

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