Job Title
Associate Director, RA UK & Ireland
All Job Posting Locations
Leeds, West Yorkshire, United Kingdom
Job Overview
The Associate Director, RA UK & Ireland provides senior regulatory leadership for the United Kingdom market, ensuring compliance with UK and applicable EU regulatory requirements while enabling timely market access and lifecycle management of DePuy Synthes products. This role has a significant impact on business continuity and growth by shaping local regulatory strategy, managing regulatory risk, and partnering closely with Commercial, Quality, Supply Chain, and Global Regulatory teams within a highly regulated environment.
Key Responsibilities
Lead and oversee regulatory affairs activities for the UK local market in alignment with global and regional regulatory strategies.
Ensure compliance with UK regulatory requirements, applicable EU MDR provisions, internal policies, and quality system standards.
Provide strategic regulatory guidance to support product registrations, variations, renewals, and lifecycle management activities.
Serve as the senior regulatory affairs point of contact and escalation lead for the UK local operating company.
Partner with Commercial, Quality, Supply Chain, and Global Regulatory teams to support compliant product distribution and business initiatives.
Monitor regulatory changes and assess potential impacts to products, portfolios, and business operations in the UK.
Lead for UKCA marking strategy for DePuy Synthes.
Support internal audits, external audits, and health authority inspections related to regulatory activities.
Lead, coach, and develop regulatory team members, fostering strong regulatory capability and compliance culture.
Ensure proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.
Qualifications
Education
Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required).
Advanced degree in a scientific or regulatory field (preferred).
Required
Typically 8–10 years of progressive experience in Regulatory Affairs within medical devices, healthcare, or another regulated industry.
Strong working knowledge of UK regulatory requirements and regulatory operating models.
Demonstrated experience leading regulatory strategy and execution at the country level.
Experience supporting audits, inspections, and health authority interactions.
Ability to manage regulatory risk and complex stakeholder environments effectively.
Experience with UKCA regulations.
Preferred
Experience working in a multinational or matrixed organization.
Familiarity with International regulatory operating models.
Experience supporting orthopedic or medical device product portfolios.
Exposure to regulatory strategy development and regulatory transformation initiatives.
Regulatory Affairs Certification (RAC) or equivalent.
Strong communication, leadership, and decision‑making skills.
Other
Language: English required.
Travel: Limited; occasional domestic or regional travel.
Certifications: Regulatory certifications preferred but not required.
Equal Opportunity Statement
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
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