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Philips Regulatory Affairs Specialist Mexico 90378052
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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:
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