- Establish safety policy for the Business, ensure the safety policy rightfully implemented in the Business
- Secure the product risk management and PH product safety policy are well understood throughout the organization and adequately followed throughout product lifecycle
- Assure activities related to product safety are addressed end-to-end
- Ensure safety related processes and governance across Business
- Understanding and application of device design, risk and (clinical) effects and safety to effectively conduct safety surveillance
- Monitor safety signal, analyze and interpret aggregate safety data.
- Recommend and drive actions in cross-functional teams
- Process expert on safety related regulatory requirements, and apply regulatory guidance as appropriate for safety surveillance
- Assure regulatory reportability assessment criteria across Business and Markets, ensure one common Philips approach to authorities on safety matters related to consumer products.
- Representing the consumer rights and needs in handling potential safety complaints.
- A Bachelor or Master's degree
- 6+ years of experience in the consumer product industry and/or medical device industry
- Consumer Care, Regulatory Affairs, Quality Assurance, Risk management or Complaint Handling experience in consumer product and or medical industry
- Demonstrated experience interacting with the relevant Authorities, NVWA, CPSC, FDA, and Other Regulatory Authorities preferred
- Strong understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods
- Demonstrated expertise in managing complex projects and implementing cultural change
- Experience with health hazard evaluations, CAPA and hands-on experience with ISO 14971 is preferred
- Excellent communications and analytical skills, excellent customer service and interpersonal communication skills
- Knowledge of RAPEX, GPSR (Geneneral Product Safety Regulation), IEC series, APPLiA
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Complaint Handling Lead - Drachten, Nederland - Philips
Beschrijving
Job Title
Complaint Handling LeadJob Description
Join our Philips Personal Health (PH) business (Post Market Surveillance team) as a Complaint Handling Lead, where you will play a pivotal role in ensuring compliance with safety-related regulatory requirements for our consumer products. You'll be responsible for establishing and implementing safety policies, conducting safety surveillance, and collaborating with cross-functional teams to analyze and interpret aggregate safety data. Make a meaningful impact on consumer satisfaction and product quality within a dynamic and motivated team. You will report to the Director, Post Market Surveillance, Personal Health.
Your role:
You will be part of a strong and motivated team within Personal Health that drives continuous consumer satisfaction by proactively monitoring post market product performance, safety, compliance and quality.
You're the right fit if:
This role requires you to either be based in Eindhoven or travel 2-3 days per week to this office.
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.
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