Senior Manager, Quality Assurance & Regulatory Affairs- UKI & Nordics in Winnersh

The Senior Manager QRA UKI and Nordics leads the Quality Assurance and Regulatory Affairs function across the region, ensuring full compliance with internal standards and external regulatory requirements. The role drives operational excellence, maintains ISO certifications, and safeguards BD’s responsibilities for products placed on the market. It includes regional representation towards Competent Authorities, guidance on local regulatory expectations, and contribution to broader EMEA QRA initiatives. The position also provides strategic partnership to commercial leadership teams and ensures strong alignment between local operations, distributors, and regional QRA direction. A central element of the role is building, developing and mentoring a high‑performing QRA team while promoting a culture of accountability, collaboration and continuous improvement.

Main Responsibilities

• Alignment between UK, Ireland and Nordics operations, distributor activities and EMEA QRA strategy
• Implementation and maintenance of the Quality Management System
• Maintenance of ISO certifications for relevant locations within scope
• Assurance of regulatory compliance for the portfolio, including registrations, AdProm, audits, pharma requirements and distributor oversight
• Representation of BD in interactions with Competent Authorities and management of regulatory submissions and communications
• Monitoring and interpretation of current and emerging regulations and recommendation of updates to systems, policies and procedures
• Oversight of accurate and consistent regulatory records and mitigation of compliance risks to secure product supply
• Leadership of the QRA team, including recruitment, development and strengthening of regulatory capabilities

About You

• Degree in Life Science, Engineering, or Physical Science; an advanced degree or MBA is a plus
• Strong experience in Regulatory Affairs management with proven expertise in compliance and regulatory frameworks
• Quality assurance experience is highly beneficial, particularly in supporting compliance and quality systems
• Solid knowledge of MDR, IVDR, ISO 13485:2016, ISO 9001:2015, with practical experience in UK regulatory environment
• Familiarity with local pharmaceutical regulations is a plus, not a core requirement
• Demonstrated first experience in a leadership role, with the ability to guide cross‑functional initiatives and drive results
• Capable of building trust and strengthening relationships from the ground up, representing BD confidently towards authorities and driving collaboration across internal and external partners

At BD, we prioritize on‑site collaboration. For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work‑life balance.

Equal Opportunity Employer – BD evaluates applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.

Salary range: £77,100.00 – £117,600.00 GBP per annum.