Description
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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Leeds, West Yorkshire, United KingdomJob Description:
DePuy Synthes is recruiting for a(n) Associate Director, RA UK & Ireland, located in Leeds, United Kingdom or Cork Ireland
Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
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.
Ensuring 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).
Experience and Skills:
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.
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Required Skills:
Preferred Skills:
Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking