In this role, you have the opportunity to
Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements and standards.
You are responsible for
• Review development quality reports and plans to ensure that the information required for submissions is adequate
• Plan, generate, and coordinate regulatory submissions for product/solution licensing in a specific marketing area
• Coordinate local registrations within this area of countries
• Review and approve product/solution labeling and product/solution-related marketing communications
• Maintain existing regulatory filings/ licenses, managing updates and related change control processes
• Assists with implementation of global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy
• Advises product design teams on regulatory strategy and requirements for specific new products/solution
• Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance
• Support development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registrations such as CE Marking and clinical evaluations
You are part of
Monitoring/Analytics & Therapeutic Care (MA &TC) designs, and develops best-in-class monitoring solutions, telemetry, clinical measurements, and clinical decision support systems that simplify clinician workflow, improve financial outcomes and help improve and save lives.
The Quality & Regulatory department supports patient care and clinical Informatics products and solutions with focus on patient monitoring. We ensure worldwide product approval and compliance with all applicable Regulations and requirement.
To succeed in this role, you should have the following skills and experience
• Engineering Degree in medical engineering, electrical engineering, mechanical engineering, informatics or similar
• 2+ years experience in Quality & Regulatory Affairs
• Good interpersonal skills and strong communication skills, team player
• Strong English written and oral communications skills
• Experience within a process oriented working environment
• High reliability and quality focus
• Medical Product knowledge;
• Demonstrated project management skills
• Experience in software and/or electrical equipment in medical industry
German language skills
In return, we offer you
Working in the medical industry brings much fulfillment, as well as unique opportunities to grow. By taking pride in all you do and inspiring others around you to prioritize Quality above all else, you’ll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.
We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
Philips encourages people with a disability to apply.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at https://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video at https://youtu.be/ocnMFp1JBuM .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at https://www.careers.philips.com/professional/global/en/workingatphilips on our career website, where you can read stories from our employee blog at https://www.careers.philips.com/global/en/blog-unexpected . Once there,you can also learn about our recruitment process at https://www.careers.philips.com/global/en/recruitmentprocess , or find answers to some of the frequently asked questions at https://www.careers.philips.com/global/en/faq .