Expoint - all jobs in one place

המקום בו המומחים והחברות הטובות ביותר נפגשים

Limitless High-tech career opportunities - Expoint

Philips Regulatory Affairs Specialist 
Mexico 
90378052

05.07.2024
Regulatory Affairs Specialist
Job Description

Guide & support Businesses, Markets and supporting functions of regulatory needs of the Mexico market for medical and non-medical products/solutions under your responsibility including the development of regulatory strategies for new and existing products/solutions, execution of regulatory submissions and engagement with external associations.

You are responsible for

  • Serving as the subject matter expert on regulatory affairs between manufacturers and internal and external stakeholders in Mexico

  • Communicating on time and accurate Mexico specific regulatory requirements and advise business partners/product design teams of regulatory strategy and requirements

  • Implementing global regulatory strategies and roadmaps through understanding competitive market landscape and product marketing strategies

  • Preparing regulatory submissions for new products/solutions, product changes, and re-registrations as required for Mexico and LATAM countries.

  • Planning and maintain registration information and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.

  • Being the subject matter expert and key point of contact for communication with Regulatory Affairs activities related to Mexico regulators, trade associations and Competent Authorities

  • Maintaining and organizing appropriate regulatory records to demonstrate compliance with applicable regulations in Mexico and LATAM.

  • Supporting development of regulatory plans, risk assessments and required activities to meet regulatory requirements and product registrations to maintain compliance

  • Acting as advisor cross- functionally to meet the schedules and/or solve technical questions

You are a part of

The Regulatory Affairs team of Latin America, where you will influence and lead the Regulatory Affairs efforts with the business.

To succeed in this role, you’ll need a customer-first attitude and the following

  • Ability to work in a matrix organization with multiple stakeholders internal and external to ensure time to market.

  • Proven successful record of accomplishment in Regulatory Affairs in Medical Devices and in Mexico with mandatory with at least 5 years of operational Regulatory Affairs experience

  • Experience with interacting with local Trade-Associations, Competent Authorities, Notified Bodies

  • Strong communication skills and influencing skills

  • Organized detailed oriented and strong decision making skills

  • Advanced English level

  • Bachelor's degree(Technical/Engineeringor Medical, Biomedical)

  • Work autonomously with established procedures and practices

In return, we offer you

Work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:

We want to be at our best:
The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.