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Regulatory Affairs Specialist
hace 2 meses
Job Title: Regulatory Affairs Specialist - Latin America
Job Description:
About the Role:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Latin America. As a key member of our Regulatory Affairs team, you will be responsible for guiding and supporting businesses, markets, and supporting functions in regulatory needs of the Mexico market for medical and non-medical products/solutions.
Key Responsibilities:
- Regulatory Strategy and Planning: Develop and implement regulatory strategies for new and existing products/solutions, ensuring compliance with Mexico and LATAM regulations.
- Regulatory Submissions: Prepare and submit regulatory submissions for new products/solutions, product changes, and re-registrations as required for Mexico and LATAM countries.
- Registration and Compliance: Maintain registration information and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.
- Regulatory Expertise: Serve as the subject matter expert on regulatory affairs between manufacturers and internal and external stakeholders in Mexico.
- Communication and Collaboration: Communicate on time and accurate Mexico specific regulatory requirements and advise business partners/product design teams of regulatory strategy and requirements.
- Global Regulatory Strategies: Implement global regulatory strategies and roadmaps through understanding competitive market landscape and product marketing strategies.
- Regulatory Records: Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations in Mexico and LATAM.
- Regulatory Planning and Risk Assessment: Support development of regulatory plans, risk assessments, and required activities to meet regulatory requirements and product registrations to maintain compliance.
- Advisor and Liaison: Act as advisor cross-functionally to meet the schedules and/or solve technical questions.
About You:
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 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, detail-oriented, and strong decision-making skills.
- Advanced English level.
- Bachelor's degree (Technical/Engineering or Medical, Biomedical).
- Work autonomously with established procedures and practices.
About Philips:
At Philips, we are committed to improving the health and well-being of billions of people, every year. We are a global leader in health technology, driven by the vision of a better tomorrow. Our team is passionate about creating innovative, customer-first health technology solutions that make a meaningful difference in people's lives.
What We Offer:
In order to develop your full potential, we will offer you the flexibility, encouragement, and opportunities to keep you inspired and engaged. We believe in creating a work environment that is inclusive, diverse, and supportive of our employees' growth and well-being.
Work Authorization:
Work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Company Relocation:
Company relocation benefits will not be provided for this position.
