Manager, RA Italy

DePuy Synthes is recruiting for a(n) Manager RA Italylocatedin Aprilia Latina Italy.

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

The Manager RA Italyis responsible forleading regulatory affairs activities for the Italy local market. This role ensures compliance with Italian and applicable EU regulatory requirements while enablingtimelymarket access and lifecycle management of DePuy Synthes products. The position plays a key role in supporting business continuity and growth by partnering closely with Commercial Quality Supply Chain and Global Regulatory teams within a highly regulated environment.

Key Responsibilities

• Lead and manage regulatory affairs activities for the Italy local market in alignment with global and regional regulatory strategies.

• Ensure compliance with Italian regulatory requirements EU MDR internal policies and quality system standards.

• Support product registrations renewals variations and regulatory lifecycle management activities.

• Serve as the primary regulatory affairs point of contact for the Italy 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 impact on products and business operations in Italy.

• Support internal audits external audits and healthauthorityinspections related to regulatory activities.

• Drive continuous improvement initiatives to enhance regulatory efficiency compliance and consistency.

• 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:

:

• Typically6-8years of experience in Regulatory Affairs within medical devices healthcare or another regulated industry.

• Strong working knowledge of Italian regulatory requirements and EU MDR.

• Experience managing regulatory submissions and product lifecycle activities.

• Experience supporting audits inspections or health authority interactions.

• Ability to manage complex regulatory topics and multiple priorities effectively.

• Strong communication stakeholder management and problemsolving skills.

Preferred:

• Experience working in a multinational or matrixed organization.

• Familiarity with regulatory operating models.

• Exposure to regulatory strategy development and execution at the country level.

• Experience supporting orthopedic or medical device portfolios.

• Regulatory Affairs Certification (RAC) or equivalent.

Other:

• Language: Italian and English.

• Travel: Limited; occasional domestic or regional travel.

• Certifications: Regulatory certifications preferred but not.

Johnson & Johnsonisan 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 federalstateor local law. We actively seek qualified candidates who areprotectedveterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnsoniscommitted to providing an interview process that isinclusive ofour applicants needs. If you are an individual with a disability and would like to requestan accommodation external applicants please contact us via internal employees contactAskGSto be directed to your accommodation resource.

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