In this role, you have the opportunity to
Develop a short- and long-term strategy per product family to interface with customers to gather additional information required for post-market safety and performance surveillance for our market leading patient monitoring systems.
You are responsible for
Support product development teams in generating a post-market surveillance plan, and conduct necessary post-market surveillance activities, such as market surveys or clinical evaluations, to ensure compliance to FDA, EU MDR, and other regulatory requirements as applicable.
Execute post-market clinical strategies to generate and capture clinical data from released products, which will satisfy regulatory requirements and drive commercial adoption.
Provide ongoing and actionable feedback to the internal stakeholders (Product Management, Clinical Affairs, R&D, etc.) to remain current on emerging product and field issues.
Liaise with quality and risk management teams to supplement customer feedback/complaints with product-specific customer surveys, clinical use data, and/or clinical investigations.
Develop and maintain data mining tools to monitor trends, and to detect emerging product and field issues, as part of a global market, as well as proactive customer engagement.
Based on surveillance findings, collaborate with technical and marketing teams to identify product improvements, and assist in establishing engineering priorities as a consequence.
Interface with corporate quality engineering for product complaints and investigations/trends, as well as supplement with clinical data as applicable for reporting purposes.
Partner with cross-functional product development, marketing, and sales team to resolve product problems and provides feedback to customers as needed.
Ensure data is collected through routine business processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality personnel.
You are part of
The Clinical Affairs team. Their goal is to ensure products/solutions meet and exceed desired clinical outcomes that affect the cost, quality and delivery of care. They are involved in all phases of product/solution development and lifecycle management. While spending 30% of their time in the market with clinicians, they internally represent the voice of the clinician and end-user, driving clinically differentiated innovations.
To succeed in this role, you should have the following skills and experience
Bachelor’s/Master degree in the medical field, biology or similar
6+ years Clinical Marketing, Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry. 4+ years’ experience with a Master or higher
Thorough knowledge of global medical device regulations relative to post-market surveillance, such as MDD, ISO 13485 / 14155/ 14971, FDA Section 522, MDR requirements, etc.
Knowledge of clinical study design, protocol development, conduct, analysis and reporting
Clinical and technical knowledge of monitoring and clinical decision support market segments in both acute and general care settings
Ability to synthesize market and customer feedback on monitoring products to identify and distinguish end-user versus product issues
Proven communication skills and ability to influence an organization (especially non direct reports) to develop solutions with validated value propositions
Fluency in written/spoken English; fluency in German is an advantage
In return, we offer you
Working in the medical industry brings much fulfillment, as well as unique opportunities to grow. 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 .