REGULATORY AFFAIRS MANAGER LATAM (MEDICAL EQUIPMENT)

Job Title Regulatory Affairs Manager Latam (Medical Equipment) Job Description Job title.
Regulatory Affairs Manager Latam (Medical Equipment) Your role.
To formulate and implement the HPM Businesses and / or Markets long-range regulatory strategies for LATAM (Latin America).
Main point of contact between BU, Market and Local Business Team for product registration preparation and renewals.
Create regulatory awareness level as determined within the organization.
Supports implementation of simplified yet robust regulatory processes for registrations and labeling deviations across the HPM Businesses.
Introduce and implement the necessary regulatory processes and tools required to ensure first time right in submissions.
Ensure compliance to relevant regulations and other Regulatory Requirements and as required, guidelines and policies to all HPM products and operations are consistent with those regulations.
Lead the Planning, generation, and coordination of regulatory submissions for HPM product/solution licensing.
Proactive stakeholder management in BU.
Define and implement appropriate regulatory certifications for sites.
Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business and / or Market.
Formulates and recommends (changes to) policies and establishes procedures that affect immediate organization(s).
Being part and execute the regulatory compliance guidance and regulatory streamline operational excellence between HPM groups /sites and Markets to ensure time to market on global initiatives especially related to new projects involving Regulatory for key decision makers.
Develop and maintain, execute and track elicit regulatory requirements as per each country required for regulatory compliance and local regulations and tracking progress of project trackers for the markets impacted against planning, submissions and approvals deadlines You're the right fit if.
(4 x bullets max) 1.
At least 8 years of experience as a regulatory manager for Latam in the medical equipment industry.
2.
You are resilient, proactive, teamwork and good listener.
3.
Bioengineering degree or similar studies.
4.
Advanced English About Philips We are a health technology company.
We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.
Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.
You may still be the right candidate for this or other opportunities at Philips.
Learn more about our commitment to diversity and inclusion here.
At Philips, we believe that every human matters.
As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation.
The people who work here share our passion and are motivated to bring this purpose to life.
For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners.
Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.
We’re committed to building a diverse and inclusive workplace culture where people feel heard, valued and connected.
Because we know the possibilities are unlimited when people feel empowered to grow and succeed together.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce.
In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of , the Vietnam Veterans' Readjustment Act of , and Title I of the Americans with Disabilities Act of , applicants that require accommodation in the job application process may contact , option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran EEO Is The Law and Supplement Poster | Pay Transparency Nondiscrimination Statement