Head of QARA
- bradford, england, United Kingdom
- Full time
- £90 - £130 Per Hour
Job Description
About Winncare At Winncare, we are dedicated to enhancing the quality of life for individuals in need of mobility and care solutions. With over four decades of expertise, we specialise in developing and providing innovative products and services that support the healthcare industry, including lifting and transfer equipment, medical beds, and a wide range of care solutions.
About Winncare At Winncare, we are dedicated to enhancing the quality of life for individuals in need of mobility and care solutions. With over four decades of expertise, we specialise in developing and providing innovative products and services that support the healthcare industry, including lifting and transfer equipment, medical beds, and a wide range of care solutions. Our commitment to excellence is driven by a passion for improving the everyday lives of patients and caregivers alike, ensuring safety, comfort, and dignity for those we serve. As a trusted partner in healthcare, Winncare continues to lead with innovation, compassion, and a relentless pursuit of quality. This is an exciting time for Winncare as we experience organisational growth and new opportunities to join our highly skilled, professional, and committed team in a great working environment. We now have a fantastic opportunity for a suitably qualified and experienced individual to join us and lead our UK QARA team in the role of Head of QARA. Employed on a full-time basis and reporting to the UK CEO, the Head of QARA will lead the UK quality and regulatory function across the full breadth of the UK business. The Head of QARA will be visible, approachable and a trusted partner to other business functions including R&D, Supply Chain, Commercial and Finance teams however this is not limited. The successful candidate will be expected to develop strong relationships, collaborate with all colleagues, and contribute to creating an environment in which roles are understood in delivering safe, effective, and compliant practices within the organisation. The UK Head of QARA will act as the Company's principal UK regulatory authority, owning MHRA relationships, CE/UKCA marking strategy and ISO 13485 Quality Management System whilst developing and fostering a culture in which QARA is an enabler and a valued resource. Key tasks and accountabilities associated with the post are as follows:
- Ensure full compliance with the UK & EU MDR, FDA 21 CFR Part 820 and proactively monitor and communicate regulatory changes and impact on the Company.
- Lead the preparation, review and maintenance of all technical documentation, Declaration of Conformity and MHRA device registrations.
- Oversee and develop the Company's vigilance system, ensuring timely and accurate reporting of adverse events, serious incidents and FSCAs to the MHRA.
- Work collaboratively with R&D, Commercial and Operations to ensure regulatory intelligence is embedded into development and product launch planning and lifecycle management.
- Act as the management representative with full accountability for the implementation, maintenance, and continual improvement of the company's BS EN ISO 13485 & 9001 certified QMS.
- Ensure the QMS is not a static document system but is a living, organisation wide framework that is understood, owned, and actively used by all departments.
- Lead management review meetings applicable across the entire UK business, ensuring and promoting cross-functional participation and actionable outputs.
- Work in close partnership with manufacturing and operations leaders to ensure that production process meets all GMP, ISO 13485 and UK & EU MDR requirements.
- Oversee all validation programmes and ensure all product & manufacturing processes are validated, monitored, and maintained.
- Lead the resolution of manufacturing NCs, ensuring root cause analysis is thorough and CAPAs are effective and sustainable.
- Engage with key opinion leaders and clinical customers to gather post-market feedback and incorporate insights into quality and regulatory planning.
- Manage and execute a comprehensive internal audit programme across all departments, adopting a collaborative and educational approach that supports rather than simply identify weaknesses or failures.
- Ensure timely, clear, and effective closure of all audit findings, working with relevant department heads to implement sustainable corrective actions.
- Prepare the UK company for future regulatory changes and evolving company ability to satisfy such changes.
- Bachelor's degree in relative subject; life sciences, biomedical engineering, pharmacy, medical or other related technical discipline.
- Lead auditor certification / ISO 13485 & Regulatory Affairs Certification or equivalent.
- Certifications in Risk Management (ISO 14971) and significant project management experience.
- Five years plus of progressive and commercially aware QARA experience in the medical device sector including leadership experience.
- Demonstratable knowledge of UK & EU MDR, MHRA & FDA regulatory process and UKCA/CE marking framework.
- Strong track record of cross functional collaboration - specific examples of working with R&D, Production, Commercial and Supply Chain.
- Acting as the PRRC and satisfying all obligations associated with this role.
- Collaboratively contribute to strategic direction of the business, providing QARA considerations to support success and progress; be solution focused.
- Demonstrate excellent communication skills and a proven ability to run large projects through proper project management. This should include transparent and clear briefing at any time and when requested.
- Develop and implement cross functional training to ensure all colleagues understand their role in maintaining compliance and quality.
- Manage the UK QARA departmental budget, ensuring resources are allocated effectively and efficiently.