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In this role, you have the opportunity to

Provide regulatory leadership for Patient Monitoring product lines and take responsibility for building and delivering on competitive regulatory strategies in China. You will work directly with Philips regulatory counterparts in China to support and achieve best possible outcomes for effective product market clearances.

You are responsible for

• Providing Regulatory Technical Competency (tactical and strategic) to the Patient Monitoring Business unit with a particular focus on China

• Participating in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards (not in the field) in order to support Marketing roadmaps for Greater China

• Reviewing development quality reports and plans to ensure that the information required for Chinese submissions is adequate

• Planning, generating, and coordinating new regulatory submissions for product/solution regulatory clearances and re-certify update current product licenses

• Coordinating testing required to support regulatory submissions

• Reviewing and approve product/solution labeling and product/solution-related marketing communications (generally at Business unit and field)

• Primary regulatory liaison between Business unit and China regulatory team

• Leading submission projects showing project management skills within Business Unit and Greater China Regulatory team

• Advising product design teams on regulatory strategy and requirements for specific new products/solutions

• Reviewing and validates marketing and labeling materials specifically for China market

You are part of

Philips Monitoring and Analytics Business researches, 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 Business sub-unit Measurement and Monitors 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 requirements.

To succeed in this role, you should have the following skills and experience

• Engineering degree (Bachelor or Master)

• 3+ years experience in Quality & Regulatory Affairs including Regulatory approval experience or 5+ years in Medical Device Industry with focus to business in or with China

• Demonstrated project management skills

• Familiar with International Regulations, Standards and QS requirements with focus on Chinese requirements

• Good interpersonal skills and strong communication skills, team player

• Strong English written and oral communications skills; fluency in German; Madarin on top is preferred

• Experience within a process oriented working environment

• High reliability and quality focus

• Medical Product knowledge

• Demonstrated project management 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 . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .