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- Tasks: Lead the Global Quality Assurance Team and oversee quality assurance programs.
- Company: Join a world-leading medical technology company focused on innovative solutions for patient outcomes.
- Benefits: Enjoy a hybrid work model with travel opportunities and a commitment to professional growth.
- Why this job: Be part of a fast-paced environment that values innovation, teamwork, and patient safety.
- Qualifications: BSc in relevant fields with expert-level knowledge in Medical Device Quality Assurance required.
- Other info: Opportunity to influence global quality standards and collaborate across divisions.
The predicted salary is between 72000 - 108000 £ per year.
Job Title: Director of Compliance
Location: United Kingdom
Job Type: Permanent Full Time
A leading healthcare company dedicated to placing patients at the centre of everything it does is seeking a seasoned and visionary Director of Compliance to lead and integrate all compliance functions (Quality Assurance, Regulatory Affairs, Sustainability, and Legal. They have a strong international presence and an expanding portfolio of cutting-edge products. The organisation is driven by a mission to enhance patient outcomes through continuous innovation and operational excellence. Reporting to the C-Suite, this senior leadership role ensures that all operations, products, and services comply with applicable industry regulations, legal requirements, and quality standards. The successful candidate will help position the organisation to achieve its global growth ambitions while enabling innovation within a robust compliance framework.
Responsibilities:
- Lead the Compliance function across Quality Assurance, Regulatory Affairs, Sustainability, and Legal.
- Provide strategic direction to embed compliance as a value driver across innovation, production, and expansion.
- Develop and implement compliance strategies aligned with corporate goals.
- Advise senior leadership on regulatory trends and emerging risks.
- Lead cross-functional compliance initiatives.
- Champion compliance as a catalyst for patient innovation and business growth.
- Stay current on regulatory frameworks including UK Medical Device Regulations, EU MDR, FDA standards, ISO standards, and sustainability legislation.
- Present complex compliance matters to senior stakeholders clearly and effectively.
- Lead audits and ensure timely implementation of corrective actions.
- Oversee global regulatory strategy and ensure compliance with all relevant regulations.
- Manage submissions for new and existing products, including technical documentation and clinical evaluations.
- Maintain relationships with regulatory bodies and resolve issues proactively.
- Develop and execute the organization’s sustainability strategy.
- Drive cross-functional sustainability programs to support long-term ESG goals.
- Oversee sustainability governance and reporting frameworks.
- Encourage collaboration on reducing environmental impact.
- Manage legal compliance for products, services, operations, and governance.
- Oversee legal risk, including IP, liability, and data protection (e.g., GDPR).
- Liaise with external legal counsel and ensure documentation aligns with regulatory needs.
- Design and maintain compliance training across the organization.
- Promote a culture of compliance and continuous improvement.
- Establish systems for regulatory monitoring and internal reporting.
- Report compliance metrics and risks to leadership and the Board.
- Maintain comprehensive records of compliance activities.
Requirements:
- Degree in Life Sciences, Engineering, Law, or related field.
- Strong knowledge of international regulatory frameworks (e.g., MDR, MDSAP, FDA, ISO 13485).
- Proven success in obtaining regulatory approvals (FDA, CE, etc.).
- Experience managing global compliance teams and working with Notified Bodies.
- Ability to influence senior leaders and boards on complex compliance issues.
- Experience leading sustainability compliance and integrating ESG principles.
- Strong communication skills, with the ability to explain technical topics to diverse audiences.
- Familiarity with ESG monitoring, sustainability projects, and AI-enabled regulatory tools.
- Legal expertise in IP, product liability, and contract law within the medical device or healthcare sector.
Please reach out to emily.james@skillsalliance.com for further details.
Director of Quality Assurance employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of Quality Assurance
✨Tip Number 1
Make sure to familiarize yourself with the latest regulations and standards in medical device quality assurance, such as ISO 13485 and US 21 CFR 820. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a fast-paced industry.
✨Tip Number 2
Network with professionals in the medical technology field, especially those who have experience in quality assurance roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in quality management.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led quality assurance initiatives in previous roles. Highlight your experience with electronic quality management systems and your ability to drive improvements in quality processes.
✨Tip Number 4
Showcase your leadership skills by discussing how you've built and managed high-performing teams in the past. Emphasize your collaborative approach and how you've worked with cross-functional teams to achieve quality objectives.
We think you need these skills to ace Director of Quality Assurance
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Director of Quality Assurance position. Understand the key responsibilities and requirements, especially the emphasis on quality management systems and regulatory compliance.
Tailor Your CV: Customize your CV to highlight relevant experience in quality assurance, particularly in the medical device industry. Emphasize your leadership skills and any experience with quality management systems like MasterControl or Trackwise.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your commitment to patient safety. Mention specific examples of how you've successfully led quality initiatives or improved processes in previous roles.
Highlight Relevant Qualifications: Make sure to clearly list your qualifications, such as your BSc in Bioscience or Biomedical Engineering, and any certifications related to quality assurance. This will help demonstrate your expertise and suitability for the role.
How to prepare for a job interview at Skills Alliance
✨Showcase Your Leadership Skills
As a Director of Quality Assurance, you'll need to demonstrate strong leadership capabilities. Prepare examples of how you've successfully led teams in the past, particularly in quality assurance settings. Highlight your experience in setting visions and aligning teams with organizational goals.
✨Understand Regulatory Standards
Familiarize yourself with key regulations such as US 21 CFR 820 and ISO 13485. Be ready to discuss how you have implemented these standards in previous roles and how you can ensure compliance within the organization. This will show your expertise and commitment to maintaining high-quality standards.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in quality assurance. Think about challenges you've faced in previous positions and how you overcame them. This will demonstrate your ability to proactively identify and manage quality-related issues.
✨Emphasize Collaboration and Communication
Quality assurance is a collaborative effort. Be prepared to discuss how you've worked with cross-functional teams to drive quality improvements. Highlight your communication skills, especially in conveying complex quality metrics and initiatives to various stakeholders, including executive management.
