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 crossfunctionally 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.

• Preparesubmit andmaintainregulatory dossiers registrations renewals and notificationsin accordance withlocal requirements.

• Act as the primary regulatory liaison with Mexican health authoritiesmaintainingeffective 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 ensuringaccurateresponses andtimelyresolution of commitments.

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

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

Qualifications

Education

• Bachelors degreein life sciences engineering ora relatedscientific discipline.

• Advanced degree preferred.

Experience and Skills

Required:

• 68 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 preparingsubmitting andmaintainingregulatory filings and approvals.

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

• Experience working in crossfunctional matrixed environments.

Preferred:

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

• Priorpeopleleadership 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 fastpaced 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).

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

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