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- 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.
Quality Assurance Regulatory Affairs Manager
Quality Assurance Regulatory Affairs Manager
This range is provided by Cure Talent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
Direct message the job poster from Cure Talent
Connecting the best talent in QARA with Innovative MedTech & STEM Organisations
Cure Talent is delighted to be working with an innovative MedTech company revolutionising ear and hearing healthcare! As part of their ongoing growth, we have a fantastic opportunity for a QARA Manager to lead and grow their Quality & Regulatory function.
We are seeking a dynamic and experienced Quality & Regulatory professional to head up the QARA team, oversee the company’s ISO 13485 certified QMS, and ensure regulatory compliance across UK, EU and global markets. This is a hands-on leadership role, offering the chance to shape the quality strategy in a fast-paced, software-driven medical device environment.
Key Responsibilities:
- Lead and manage the QARA team, ensuring clear direction, support and development.
- Oversee the QMS and ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR and EN 62304.
- Govern quality system activities including CAPA, non-conformances, change controls, internal audits and training.
- Maintain Design History Files and Technical Documentation to support global market access.
- Provide regulatory input across the software and product development lifecycle.
- Prepare for and host external audits and inspections.
- Work cross-functionally to embed quality into operations, engineering and commercial teams.
- Stay up to date with evolving global regulations and guide internal teams accordingly.
The Ideal Candidate Will Have:
- Proven experience leading QA/RA teams in the Medical Device industry.
- Strong knowledge of ISO 13485, EU MDR, FDA QSR and EN 62304.
- Background in Software as a Medical Device (SaMD) is highly desirable.
- Experience managing audits, CAPA processes, and regulatory submissions.
- A collaborative leadership style with the ability to work at both strategic and operational levels.
- Excellent communication and organisational skills.
If you\’re looking for an exciting opportunity to lead quality and regulatory operations within a high-growth, purpose-driven MedTech company, get in touch today!
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance
-
Industries
Medical Equipment Manufacturing
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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.
