Job Title
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Manager, RA Italy
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: 6-8 years 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.
Benefits
* Base pay range: €56,100.00 - €96,945.00.
* Annual bonus with set target (% of pay) based on performance.
* Vacation days, parental leave (minimum 12 weeks), bereavement leave, caregiver leave, volunteer leave, well‐being reimbursement.
* Insurance plans and service anniversary and recognition awards.
* Other benefits may vary by location and are subject to change. xrdztoy
Equal Opportunity Employer
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.