Position: Director of Quality Assurance & Regulatory Affairs
Location: Middlesex
Salary: £85K + benefits
Purpose of the Role
To lead global quality and regulatory strategy, ensuring compliance across the company's product portfolio. This role is pivotal in enabling market access, maintaining high standards, and embedding quality throughout the product lifecycle.
Strategic Leadership
Represent role model or servant leader model leadership as a member of senior site management team.
Develop and implement the QARA strategy aligned with business goals and regulatory compliance requirements.
Collaborate with Engineering, Operations, and Commercial teams to integrate quality and compliance from concept to delivery.
Represent the company in regulatory compliance audits and external engagements.Regulatory Affairs
Oversee global product registrations and submissions, including CE marking and international approvals for company products
Support in defining regulatory pathways early in product development, including Intended Use and Risk Classification.
Ensure compliance with ISO 13485, MDR, FDA 21 CFR Part 820, and other relevant standards.Quality Assurance
Maintain and enhance the Quality Management System (QMS).
Lead internal and supplier audits, investigations, and corrective actions.
Analyse QA data to drive continuous improvement and risk mitigation.Project Oversight
Lead QARA team in managing regulatory documentation and audit readiness.
Support change control and post-market surveillance activities.Team Development
Mentor and develop QARA team members.
Ensure training programmes reflect current regulatory and quality practices.
Skills & Experience
Proven leadership in QARA within medical devices or regulated industries.
Strong engineering background
Experience with CE marking, Medical Device Requirements, both EU and UK, regulatory submissions, electrical safety requirements, software validation, and international compliance.
Excellent communication and stakeholder engagement skills.
Familiarity with electronic QMS and project management tools.Desirable Qualifications
Degree in Engineering, Life Sciences, or related field (Master's preferred).
Experience working directly with regulatory bodies.
Lead Auditor Certification
About Us
We are dedicated to fostering a diverse and inclusive community. In line with our Diversity and Inclusion policy, we welcome applications from all qualified individuals, regardless of age, gender, ethnicity, sexual orientation, or disability. As a Disability Confident Employer, and part of the Nicholas Associates Group, we are committed to supporting candidates with disabilities, and we're happy to discuss flexible working options.
We are committed to protecting the privacy of all our candidates and clients. If you choose to apply, your information will be processed in accordance with the Nicholas Associates Group of companies