Description
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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Madrid, SpainJob Description:
DePuy Synthes is recruiting for a Manager, RA Spain located in Madrid, Spain
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics 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 Spain is responsible for leading regulatory affairs activities across Spain and Portugal, ensuring compliance with local and regional regulatory requirements. This role supports product registrations, renewals, and lifecycle management while enabling timely market access and business continuity. The position plays a key role in partnering with local, regional, and global stakeholders to navigate regulatory complexity and support sustainable growth within DePuy Synthes.
Key Responsibilities
Lead and manage regulatory affairs activities to support product registrations, renewals, and lifecycle management for Spain and Portugal.
Ensure compliance with EU, local regulatory requirements, internal policies, and quality system standards.
Serve as the primary regulatory point of contact for Spain and Portugal local markets.
Coordinate regulatory submissions, variations, renewals, and responses to health authority inquiries.
Partner with cross‑functional teams including Quality, Supply Chain, Commercial, and Global Regulatory Affairs.
Monitor changes in EU and local regulatory requirements and assess potential impact on products and operations.
Support regulatory audits, inspections, and health authority interactions as required.
Contribute to continuous improvement initiatives to enhance regulatory efficiency, compliance, and effectiveness.
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 or professional certification in Regulatory Affairs (preferred).
Experience and Skills:
Required:
Typically 6-8 years of progressive experience in Regulatory Affairs within the medical device, healthcare, or regulated industry.
Strong knowledge of EU MDR and regulatory requirements applicable to Spain and Portugal.
Experience managing product registrations and lifecycle activities in EU markets.
Ability to interpret and apply regulatory requirements to business and product decisions.
Strong stakeholder management, communication, and collaboration skills.
Ability to manage multiple priorities in a complex, fast‑paced environment.
Must meet the Technical Responsible Person requirements of Article 8 of Royal Decree 192/2023. A relevant university degree, typically Pharmacy, Engineering, Chemistry or similar scientific discipline. Demonstrable experience in medical devices. Training appropriate to type and volume of activity and familiarity with quality management systems (ISO 13485).
Preferred:
Experience supporting multi‑country market portfolios.
Familiarity with global regulatory frameworks and harmonization initiatives.
Experience working in a multinational or matrixed organization.
Exposure to regulatory audits, inspections, or notified body interactions.
Demonstrated experience driving regulatory process improvement initiatives.
Other:
Language: English required; Spanish and/or Portuguese preferred.
Travel: Moderate regional travel within Spain and Portugal.
Certifications: RAC or equivalent 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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Required Skills:
Preferred Skills:
Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility