Job Title

Regulatory Affairs Specialist

Job Description

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

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

1. Serving as the subject matter expert on regulatory affairs between manufacturers and internal and external stakeholders in Mexico.
2. Communicating on time and accurate Mexico specific regulatory requirements and advise business partners/product design teams of regulatory strategy and requirements.
3. Implementing global regulatory strategies and roadmaps through understanding competitive market landscape and product marketing strategies.
4. Preparing regulatory submissions for new products/solutions, product changes, and re-registrations as required for Mexico and LATAM countries.
5. Planning and maintaining registration information and obtaining re-registration approvals in advance of license expirations to ensure no disruption in product availability.
6. 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.
7. Maintaining and organizing appropriate regulatory records to demonstrate compliance with applicable regulations in Mexico and LATAM.
8. Supporting development of regulatory plans, risk assessments and required activities to meet regulatory requirements and product registrations to maintain compliance.
9. 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

1. Ability to work in a matrix organization with multiple stakeholders internal and external to ensure time to market.
2. Proven successful record of accomplishment in Regulatory Affairs in Medical Devices and in Mexico with mandatory at least 5 years of operational Regulatory Affairs experience.
3. Experience with interacting with local Trade-Associations, Competent Authorities, Notified Bodies.
4. Strong communication skills and influencing skills.
5. Organized, detailed oriented and strong decision making skills.
6. Advanced English level.
7. Bachelor's degree (Technical/Engineering or Medical, Biomedical).
8. Work autonomously with established procedures and practices.

In return, we offer you

In order to develop your full potential, we will offer you the flexibility, encouragement, and opportunities to keep you inspired and engaged. After all, working at Philips is more than a job. It is an experience full of amazing moments that will transform you in a lasting and positive way since together we can improve the world.

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

Company relocation benefits will not be provided for this position.

How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.

Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.