Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead the QARA team and ensure compliance with global regulations in a fast-paced MedTech environment.
- Company: Join an innovative MedTech company transforming ear and hearing healthcare.
- Benefits: Enjoy a full-time role with opportunities for growth and development in a dynamic industry.
- Why this job: Shape quality strategy while making a real impact in healthcare technology.
- Qualifications: Experience in QA/RA within the Medical Device industry and knowledge of ISO standards required.
- Other info: Ideal for those passionate about quality assurance and regulatory affairs in a purpose-driven company.
The predicted salary is between 43200 - 72000 £ per year.
Cure Talent are delighted to be partnered with an established medical device manufacturer as they continue to strengthen their Quality and Regulatory capability. We have an exciting opportunity for a Quality & Regulatory Manager to join their leadership team and ensure ongoing compliance with global standards and regulations.
As the new Quality & Regulatory Manager, you will lead a small team and take responsibility for maintaining compliance with ISO 13485, MDR 2017/745, and other international frameworks. Acting as the Person Responsible for Regulatory Compliance (PRRC), you will oversee product registrations, QMS performance, technical documentation, and post-market activities, while driving a culture of quality and continuous improvement across the business.
Key Responsibilities
- Act as the Person Responsible for Regulatory Compliance
- Lead and mentor the QA/RA team, managing workloads, budgets, and resources effectively.
- Maintain compliance with ISO 13485 and other applicable international standards.
- Manage the preparation and maintenance of product registrations, technical documentation, and regulatory files.
- Oversee document control and ensure regulatory documentation meets all agency requirements.
- Plan and manage internal audit activities and drive continuous improvement initiatives.
- Lead CAPA, non-conformance, complaint handling, vigilance, and post-market surveillance processes.
Experience and Skills Required
- Proven QARA leadership experience within the medical device industry.
- Proven experience in UK, EU, US, and Canadian regulatory submissions.
- Strong working knowledge of ISO 13485, MDR 2017/745, and international quality standards.
- Experience managing quality teams and leading audits and inspections.
- Degree in Life Sciences or Engineering; microbiology or dermatology experience desirable.
If you\’re an experienced QA/RA professional seeking a leadership opportunity to shape quality and regulatory strategy within an established medical device business, we\’d love to hear from you.
Quality Assurance Regulatory Affairs Manager employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the latest updates on ISO 13485, EU MDR, and FDA regulations. Being well-versed in these standards will not only boost your confidence during interviews but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the MedTech industry, especially those who have experience in Quality Assurance and Regulatory Affairs. Attend relevant conferences or webinars to make connections and gain insights that could give you an edge in your application.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led QA/RA teams in the past. Highlighting your leadership style and collaborative approach will resonate well with hiring managers looking for a dynamic candidate.
✨Tip Number 4
Research the company’s products and their impact on ear and hearing healthcare. Showing genuine interest in their mission and how you can contribute to their goals will set you apart from other candidates.
We think you need these skills to ace Quality Assurance Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance and Regulatory Affairs, particularly in the medical device industry. Emphasise your knowledge of ISO 13485, EU MDR, and FDA regulations.
Craft a Compelling Cover Letter: Write a cover letter that showcases your leadership skills and experience managing QA/RA teams. Mention specific examples of how you've successfully overseen compliance and quality systems in previous roles.
Highlight Relevant Skills: In your application, clearly outline your skills related to CAPA processes, audits, and regulatory submissions. Use keywords from the job description to ensure your application stands out.
Showcase Your Collaborative Approach: Demonstrate your ability to work cross-functionally by providing examples of past collaborations with engineering and commercial teams. This will show that you can embed quality into various operations.
How to prepare for a job interview at Cure Talent
✨Showcase Your Leadership Skills
As a Quality Assurance Regulatory Affairs Manager, you'll be leading a team. Be prepared to discuss your leadership style and provide examples of how you've successfully managed teams in the past, especially in high-pressure environments.
✨Demonstrate Regulatory Knowledge
Familiarise yourself with ISO 13485, FDA QSR, and EU MDR regulations. Be ready to discuss how you have applied these standards in previous roles and how you stay updated with evolving regulations.
✨Prepare for Technical Questions
Expect questions related to quality management systems and regulatory compliance processes. Brush up on CAPA, non-conformances, and internal audits, and be ready to explain your approach to these areas.
✨Emphasise Cross-Functional Collaboration
This role requires working closely with various teams. Prepare examples of how you've successfully collaborated with engineering, operations, and commercial teams to embed quality into their processes.
