Manager, RA Mexico

DePuy Synthes is recruiting for a Manager, RA Mexico located in Mexico City Mexico

Job Overview 

The Manager, Regulatory Affairs Mexico provides regulatory leadership to support the successful introduction, maintenance, and compliance of DePuy Synthes medical devices in the Mexico market. This role plays a critical part in enabling patient access to innovative orthopedic solutions while ensuring adherence to local regulatory requirements. The position offers the opportunity to work cross‑functionally and influence business outcomes in a dynamic, highly regulated environment. 

Key Responsibilities 

• Lead and manage regulatory submission, approval, and lifecycle activities for medical devices in Mexico. 

• Develop and execute regulatory strategies that support new product introductions, product changes, and ongoing compliance. 

• Prepare, submit, and maintain regulatory dossiers, registrations, renewals, and notifications in accordance with local requirements. 

• Act as the primary regulatory liaison with Mexican health authorities, maintaining effective and professional working relationships. 

• Interpret regulatory requirements and clearly communicate risks, timelines, and impacts to internal stakeholders. 

• Partner with Quality, Supply Chain, R&D, and Commercial teams to ensure regulatory compliance throughout the product lifecycle. 

• Support regulatory inspections, audits, and inquiries, ensuring accurate responses and timely resolution of commitments. 

• Contribute to continuous improvement of regulatory processes and promote a strong culture of compliance. 

• Provide guidance, coaching, and day‑to‑day direction to regulatory team members or project contributors, as applicable. 

Qualifications 

Education 

• Bachelor’s degree required in life sciences, engineering, or a related scientific discipline. 

• Advanced degree preferred. 

Experience and Skills 

Required: 

• 6–8 years of progressive experience in Regulatory Affairs within the medical device industry. 

• Strong knowledge of regulatory requirements and product lifecycle management for medical devices. 

• Proven experience preparing, submitting, and maintaining regulatory filings and approvals. 

• Ability to interpret regulations and translate regulatory requirements into practical business guidance. 

• Experience working in cross‑functional, matrixed environments. 

Preferred: 

• Experience supporting product launches and significant product changes in regulated markets. 

• Prior people leadership or project leadership experience. 

• Experience working with global Regulatory Affairs teams and aligning local activities with global strategies. 

• Demonstrated ability to manage multiple priorities in a fast‑paced environment. 

• Familiarity with U.S. and/or European medical device regulatory frameworks. 

• Strong written and verbal communication skills with the ability to engage internal and external stakeholders. 

Other: 

• Languages: Fluency in Spanish and English (written and verbal) required. 

• Travel: Moderate, primarily domestic with occasional international travel. 

• Certifications: Regulatory Affairs certification preferred. 

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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