Manager, RA Italy

DePuy Synthes is recruiting for a(n) Manager, RA Italy located in Aprilia, Latina, Italy. 

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 Manager, RA Italy is responsible for leading regulatory affairs activities for the Italy local market. This role ensures compliance with Italian and applicable EU regulatory requirements while enabling timely market 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 health authority inspections 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: 

• 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 6-8 years 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 problem‑solving 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 required. 

• Travel: Limited; occasional domestic or regional travel. 

• Certifications: Regulatory certifications preferred but not required. 

 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. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. 

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