- Regulatory Affairs, Safety & Compliance of consumer products/services including medical and cosmetic products. As a legal manufacturer, you make sure that all Philips PH products being released are in compliance with all relevant safety and environmental policies and regulations by implementing and setting requirements, conditions and enablers.
- Representing Philips PH in the lobbying/other discussions with European and other national governments and industry associations and influencing standardization bodies in the scope of product safety, product performance and efficacy. Preventing surprises of unknown legislation resulting in sales or reputation damage.
- Preparation of regulatory strategies for business and alignment with regulators. Ensuring that all products (including medical) are aligned with legislation or regulations and Philips policies. Facilitate speed-to-market, to achieve all pre-market timelines and landmarks.
- Preparing safety policy, keeping it aligned with new regulations and standards, having it approved, deploying and implementing these policies. Representing Philips to authorities in case of safety incidents or alleged product non-compliance. Initiating sales stops or recall of products from the market.
- Ensuring a motivated and proficient team. Defining and implementing accurate organization and budget, hiring right people and ensuring that and projects are accurately running.
- Advising product and solutions teams to ensure timely, effective and efficient transition to new requirements. Mentoring and training others to optimally do the same.
- Ensure worldwide market access and compliance to local regulatory requirements
- Master's degree (Engineering or Medical/ biomedical background)
- A minimum of 8 years' experience in RA in an International environment of which at least 5 years in Medical Devices (Class 1 and 2) is required
- FDA and EU MDR experience is a must
- Affinity with Cosmetic, Product Safety and Food Contact
- Experience in Project management (within Regulatory Affairs) is an advantage
- Strong communicative and stakeholder management skills
- Prepared to travel up to 20% globally
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
- Learn more about our business .
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits .
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Head of Regulatory Affairs, Personal Health - Nederland - Philips International
Beschrijving
Head of Regulatory Affairs, Personal Health page is loaded
Head of Regulatory Affairs, Personal Health
Apply locations Eindhoven Amsterdam Farnborough Drachten time type Full time posted on Posted 2 Days Ago job requisition idJob Title
Head of Regulatory Affairs, Personal HealthJob Description
Head of Regulatory Affairs, Personal Health
Support the innovation of services/products focusing on improving people's life. You lead a global Regulatory Affairs (RA) team delivering Regulatory Intelligence and product compliance for all 3 Business Units and formally represent the Philips Consumer Lifestyle B.V. Legal Manufacturer entity. You will also lead a team of international market Regulatory Affairs enabling worldwide market access of the Personal Health product portfolio. You will report to the Vice President RA and take part in the Leadership team on RA and be member of the Philips PH extended Leadership team. Your focus will be on household appliances, consumer Medical Devices and Cosmetics, Food Contact, Toys (Baby care) and overall Product Safety and compliance.
Your role:
You're the right fit if:
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 improve the lives of others.
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 .
Similar Jobs (1) Communications Director, Personal Health
locations Amsterdam time type Full time posted on Posted 18 Days AgoAt 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 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact , option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran
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