At a Glance
- Tasks: Lead and develop quality and regulatory functions in a medical device company.
- Company: Growing medical device organisation focused on quality excellence.
- Benefits: Competitive salary, career development, and a chance to shape industry standards.
- Other info: Join a dynamic team with opportunities for professional growth and mentorship.
- Why this job: Make a real impact in healthcare by ensuring product quality and compliance.
- Qualifications: Proven leadership in QA/RA, knowledge of ISO 13485 and EU MDR required.
The predicted salary is between 60000 - 80000 € per year.
We are seeking an experienced and strategic Head of QA/RA to lead and develop our clients Quality and Regulatory function within a growing medical device organisation. This is a critical leadership role responsible for ensuring compliance with global regulatory requirements, driving quality excellence, and supporting the business through product development and commercialisation.
The successful candidate will play a key role in shaping and maintaining a robust Quality Management System (QMS), ensuring alignment with ISO 13485 and EU MDR, while building and mentoring a high-performing QA/RA team.
Key Responsibilities- Quality & Compliance Leadership
- Lead the development, implementation, and continuous improvement of the company’s Quality Management System (QMS) in line with ISO 13485 and applicable regulatory requirements.
- Ensure ongoing compliance with EU MDR (2017/745) and other global regulatory frameworks.
- Act as the primary Quality and Regulatory representative for internal and external stakeholders.
- Regulatory Affairs
- Oversee regulatory strategy, submissions, and approvals for medical devices across key markets.
- Ensure timely and accurate regulatory filings and maintenance of technical documentation.
- Maintain awareness of evolving regulatory requirements and implement necessary changes.
- Audit & Inspection Readiness
- Lead internal and external audits, including notified body and regulatory authority inspections.
- Maintain audit readiness at all times.
- Serve as Lead Auditor, conducting internal audits and overseeing audit programmes.
- Team Leadership & Development
- Build, lead, and develop a high-performing QA/RA function.
- Recruit, mentor, and retain talent within the quality and regulatory team.
- Foster a strong quality culture across the business.
- Cross-Functional Collaboration
- Partner with R&D, Manufacturing, and Commercial teams to ensure quality and regulatory considerations are embedded throughout the product lifecycle.
- Provide strategic input to senior leadership on quality and regulatory matters.
- Experience & Qualifications
- Proven experience in a senior QA/RA leadership role within the medical device industry.
- Strong working knowledge of ISO 13485 and EU MDR (2017/745).
- Demonstrated experience building and managing a QMS.
- Track record of hiring and developing QA/RA teams.
- Certified Lead Auditor (ISO 13485 or equivalent) essential.
- Experience leading audits with notified bodies and regulatory authorities.
Quality Assurance in Gloucester employer: PROJECTUS
Join a dynamic and innovative medical device organisation that prioritises quality and regulatory excellence. As a leader in the field, we offer a collaborative work culture that fosters professional growth and development, with opportunities to mentor a high-performing team while ensuring compliance with global standards. Located in a thriving industry hub, our company provides a supportive environment where your expertise will directly impact product development and commercialisation, making a meaningful difference in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance in Gloucester
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Quality Assurance role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and EU MDR. Be ready to discuss how you've implemented these standards in past roles. Show us that you’re not just familiar with the regulations, but that you can lead a team to excel in compliance.
✨Tip Number 3
Don’t underestimate the power of a strong online presence. Update your LinkedIn profile to reflect your QA/RA expertise and connect with industry leaders. Engage with relevant content to showcase your passion for quality management and regulatory affairs.
✨Tip Number 4
Apply directly through our website! We love seeing candidates who take the initiative. Tailor your application to highlight your leadership experience in building high-performing QA/RA teams and your success in maintaining audit readiness.
We think you need these skills to ace Quality Assurance in Gloucester
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Assurance role. Highlight your experience with ISO 13485 and EU MDR, and showcase any leadership roles you've had in QA/RA. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality and regulatory affairs in the medical device industry. Share specific examples of how you've led teams or improved QMS in previous roles. We love a good story!
Showcase Your Leadership Skills:Since this is a leadership role, make sure to highlight your experience in building and mentoring teams. Talk about how you've fostered a strong quality culture and collaborated with cross-functional teams. We’re keen on seeing your leadership style!
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team at StudySmarter!
How to prepare for a job interview at PROJECTUS
✨Know Your Regulations
Make sure you brush up on ISO 13485 and EU MDR before the interview. Being able to discuss these regulations confidently will show that you’re not just familiar with them, but that you can lead compliance efforts effectively.
✨Showcase Your Leadership Skills
Prepare examples of how you've built and developed high-performing QA/RA teams in the past. Highlight your mentoring experiences and how you foster a strong quality culture, as this is crucial for the role.
✨Audit Readiness is Key
Be ready to discuss your experience with audits and inspections. Share specific instances where you led internal audits or prepared for external inspections, demonstrating your commitment to maintaining audit readiness.
✨Cross-Functional Collaboration
Think of examples where you partnered with R&D, Manufacturing, or Commercial teams. Showing that you understand the importance of embedding quality and regulatory considerations throughout the product lifecycle will set you apart.
