Regulatory Compliance Specialist

6 days ago


Derby, Derby, United Kingdom Robertson Recruitment Services Full time

Regulatory Officer

We are seeking a skilled Regulatory Officer to join our team at Robertson Recruitment Services. The successful candidate will be responsible for maintaining the company's compliance to ISO13485, European and UK Medical Device Directives/Regulations and US FDA Regulations 21CFR part 820.

Key Responsibilities:

  • Assist with the upkeep and creation of Technical Files
  • Provide support with product data collection and reviews
  • Assist with on-time fulfilment of compliance and regulatory changes
  • Control and maintain product specifications
  • Maintain relationships with customers
  • Communicate with competent authorities on matters relating to new products, incidents and recalls
  • Participate with the change control process for new product introduction and alterations

Requirements:

  • Relevant QMS/Regulatory educational and training qualifications
  • Strong understanding of regulatory requirements and compliance
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team

Working Hours:

Monday to Friday - 08:00 - 16:30pm (can be flexible with start times/finishes)



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