Regulatory Affairs Specialist

hace 4 meses

Huixquilucan de Degollado, México Philips A tiempo completo

**Job Title**: Regulatory Affairs Specialist

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**
- 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.
- 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/Engineering or Medical, Biomedical)
- 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.

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.
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 believe in the importance of impactful collaboration:_ There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
- We embrace flexibility:_ Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
- 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.

**Why should you join Philips?**
Working at Philips is more than a job. It’s a calling to cr

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