Manager, Regulatory Affairs Spain

Job Overview

The Manager RA Spainis responsible forleading 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 enablingtimelymarket 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 crossfunctional 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.

• 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:

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

• Advanced degree or professional certification in Regulatory Affairs (preferred).

Experience and Skills:

Required:

• Typically6-8 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 fastpaced environment.

• Must meet the Technical Responsible Person requirements of Article 8 of Royal Decree 192/2023.A relevant university degree typically Pharmacy EngineeringChemistryor similar scientific discipline.Demonstrable experience in medical devices. Trainingappropriate totype and volume of activity and familiarity with quality management systems (ISO 13485).

Preferred:

• Experience supporting multicountry 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; Spanish and/or Portuguese preferred.

• Travel: Moderate regional travel within Spain and Portugal.

• Certifications: RAC or equivalent preferred but not.

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 internal employees contact AskGS to be directed to your accommodation resource.

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