Regulatory Compliance Specialist
4 weeks ago
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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