Associate Director, RA UK & Ireland

DePuy Synthes is recruiting for a(n) Associate Director RA UK& Irelandlocatedin Leeds UnitedKingdomor Cork Ireland

Johnson & Johnson announced plans to separate our Orthopedics business toestablisha standalone orthopedics companyoperatingas DePuy Synthes. The process of the planned separation isanticipatedto be completed within 18 to24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be regulatory approvals and other customary conditions and approvals. Should you accept this position it isanticipatedthat following conclusion of the transaction you would be an employee of DePuySynthesand your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes atan appropriate timeand subject to any necessary consultation processes.

Job Overview

TheAssociate Director RA UK& Irelandprovides senior regulatory leadership for the United Kingdom market ensuring compliance with UK and applicable EU regulatory requirements while enablingtimelymarket 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.

• Providestrategic 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 impactstoproducts portfolios and business operations in the UK.

• Lead for UKCA marking strategy for DePuy Synthes

• Support internal audits external audits and healthauthorityinspections 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:

• Bachelors degree in Regulatory Affairs Life Sciences Engineering ora relateddiscipline (required).

• Advanced degree in a scientific or regulatory field (preferred).

Experience and Skills:

:

• Typically810 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 withInternationalregulatory operating models.

• Experience supporting orthopedic or medical device product portfolios.

• Exposure toregulatory strategy development and regulatory transformation initiatives.

• Regulatory Affairs Certification (RAC) or equivalent.

• Strong communication leadership and decisionmaking skills.

Other:

• Language: English.

• Travel: Limited; occasional domestic or regional travel.

• Certifications: Regulatory certifications preferred but not.

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