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| Job Location | Cambridge |
| Education | Not Mentioned |
| Salary | Competitive salary |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
Job Title: Quality Assurance and Regulatory Affairs SpecialistLocation: Cambridge(Hybrid, 2-3 days per week onsite)About:A distinguished medical device company based in Cambridge, dedicated to pioneering innovative healthcare solutions is seeking a highly skilled and motivated individual to join its team as a Quality Assurance and Regulatory Affairs Specialist. The successfulcandidate will play a pivotal role in ensuring that the companys products align with regulatory requirements and maintain the highest standards of quality.Responsibilities:Regulatory Compliance: Ensure alignment of products with local and international regulatory requirements.Quality Management: Implement and sustain effective quality management systems to uphold product quality standards.Documentation: Prepare and submit precise and comprehensive regulatory documents.Audits and Inspections: Coordinate and actively participate in internal and external audits, including regulatory agency inspections.Risk Management: Conduct thorough risk assessments and devise strategies to mitigate potential quality and regulatory risks.Cross-Functional Collaboration: Collaborate with cross-functional teams to support product development, manufacturing, and post-market surveillance activities.Requirements:Bachelors degree in a relevant scientific quality assurance or engineering discipline.Minimum of 3 years of experience in quality assurance and/or regulatory affairsKnowledge of regulatory requirements for medical devices (ISO 13485, FDA, MDSAP etc.).Strong comprehension of quality management systems and practices.Excellent communication and interpersonal skills.Proven ability to work collaboratively in a fast-paced and dynamic environment.Must already have right to work in the UK - sorry