Role
Medical Device QA/ Regulatory Affairs Specialists/Deputy play a crucial role in assisting with activities required to meet Quality /Medical device and IVD Standards and regulations. They will also monitor and advise on the performance of the quality management system and will produce data and generate reports on performance, measuring against set indicators.
Role Specific Responsibilities and duties, directly or through their team:
* Ensuring medical devices comply with all applicable regulatory requirements and standards
* Preparing and submitting regulatory applications, or submissions
* Communicating with regulatory authorities, to respond to inquiries and negotiate compliance
* Monitoring and staying up-to-date on changes in domestic and international medical device regulations
* Assisting in the development of regulatory strategies and compliance initiatives
* Maintaining thorough documentation and records to demonstrate regulatory compliance
Job Types: Full-time, Permanent
Pay: £35,000.00-£37,500.00 per year
Benefits:
* On-site parking
Work Location: In person