Senior Global Platform Regulatory Strategist

Merit Medical; Tijuana; Presencial; MXN 600.000 - 1.100.000; Jornada completa

Descripción de la vacante

Merit Medical in Mexico (Tijuana) seeks an experienced Regulatory Affairs professional to align regulatory goals with the company’s strategic priorities. You will collaborate with Marketing, R&D, Operations and Quality Assurance to ensure global submissions meet evolving requirements.

The role demands strong knowledge of medical device regulations and hands-on experience with health authorities such as FDA, Notified Bodies and Health Canada; RAC certification is preferred.

Formación

• 8 years of progressive Regulatory Affairs experience in the medical device industry.
• Advanced English level.
• Prior experience in medical industry.
• Prior experience with health authorities and regulatory agencies (e.g., U.S. FDA, European Notified Bodies, Health Canada).
• Knowledge of global medical device regulations and Quality System Standards (ISO 13485, etc.).
• RAC certification strongly preferred.

Responsabilidades

• Collaborates with key stakeholders to align regulatory goals with business priorities.
• Develops and maintains strategic partnerships with Marketing, R&D, Operations, Clinical Affairs and Quality Assurance.
• Ensures activities comply with evolving global regulatory requirements for assigned platforms and operations projects.
• Maintains product knowledge and supports global submissions with organized data.
• Partners with Regional RA to develop, align and execute regulatory strategies for projects and changes.
• Represents Merit in interactions with regulatory authorities to strengthen credibility.
• Supports and suggests continuous improvement of regulatory processes, procedures and policies.
• Ensures regulatory data is accurate and up-to-date; informs teams of regulatory changes.

Conocimientos

Advanced English

Regulatory knowledge

Attention to detail

Educación

Bachelor’s degree in life sciences, engineering, regulatory affairs or related discipline

Herramientas

Regulatory software

Descripción del empleo

Merit Medical in Mexico (Tijuana) seeks an experienced Regulatory Affairs professional to align regulatory goals with the company’s strategic priorities. You will collaborate with Marketing, R&D, Operations and Quality Assurance to ensure global submissions meet evolving requirements.

The role demands strong knowledge of medical device regulations and hands-on experience with health authorities such as FDA, Notified Bodies and Health Canada; RAC certification is preferred.