At a Glance
- Tasks: Develop and implement quality assurance strategies for innovative medical devices.
- Company: A growing MedTech company in Cambridge with a team of experts.
- Benefits: Competitive salary, performance bonuses, pension scheme, and free lunches.
- Other info: Full-time office role with opportunities for professional growth.
- Why this job: Join a dynamic team and shape the future of medical technology.
- Qualifications: 2-5 years in quality assurance or regulatory affairs in MedTech.
The predicted salary is between 40000 - 50000 £ per year.
A growing medical devices company in Cambridgeshire is seeking an experienced QARA specialist to join our team of experts.
Responsibilities
- Develop and implement quality assurance and regulatory strategies for medical devices launched in Europe, North America and APAC.
- Ensure compliance with ISO 13485, CE Marking and other relevant standards across design and manufacturing processes.
- Conduct internal audits to verify adherence to regulatory and quality requirements.
- Collaborate with cross‑functional teams to maintain regulatory best practice throughout the product lifecycle.
- Shape and continuously improve quality and regulatory processes.
Qualifications
- Minimum of 2 to 5 years of experience in quality assurance or regulatory affairs within the medical device industry.
- Strong knowledge of ISO 13485, CE Marking and related UK/European regulatory standards.
- Background in engineering, biomedical engineering or a related scientific discipline (minimum bachelor’s degree).
- Scientific background acceptable.
- Experience performing internal audits.
Benefits
- Competitive salary package with performance bonus.
- Company pension scheme.
- Free lunches and other benefits.
Please note the position is based full‑time in the office. If you would like to find out more about the company and this role, please submit a confidential application.
Quality Assurance & Regulatory Affairs Specialist - MedTech in Cambridge) employer: Newton Colmore Consulting
Join a dynamic and innovative medical devices company in Cambridge, where your expertise as a Quality Assurance & Regulatory Affairs Specialist will be valued and nurtured. With a strong focus on employee growth, we offer competitive salaries, performance bonuses, and a supportive work culture that encourages collaboration and continuous improvement. Enjoy unique benefits such as free lunches and a company pension scheme, all while contributing to meaningful advancements in healthcare technology.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance & Regulatory Affairs Specialist - MedTech in Cambridge)
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We think you need these skills to ace Quality Assurance & Regulatory Affairs Specialist - MedTech in Cambridge)
Some tips for your application 🫡
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Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Newton Colmore Consulting that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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