In this role, you have the opportunity to
Be part of a fast-growing business that help improve the lives of millions of people, while advancing Philips digital transformation journey as a global leader in Health Technology. You will manage a team of about 11 Complaint Handlers, Vigilance Reporting and Post Market Surveillance Specialists.
You are responsible for
Leading, developing, supporting and guiding the Complaints Handling, Vigilance Reporting, and Post Market Surveillance team located in Best, Netherlands, and Bangalore, India. Ensuring that complaints are timely evaluated to determine reportability according to worldwide regulations, and that Medical Device reports are timely submitted (initial, follow up and final reports)
Keeping up to date on changes in regulations and standards, and ensuring that the Vigilance Reporting team is trained on applicable regulations and standards and any other training required to execute complaint investigations
Working with a variety of diverse persons within the company such as Business Leads, Risk Managers, Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate complaints investigations and reportable device events in accordance with written procedures and global reporting requirements
Reviewing Medical Device Regulations/Management Information Reports ensuring that the information is accurate and complete as per applicable requirements
Supporting and participating in internal and external audits as the Subject Matter Expert on Adverse Event reporting, Complaints Handling, and Post Market Surveillance.
Supporting activities around EU MDR compliance in relation to Adverse Event reporting
Monitoring metrics and driving process improvements based on performance against metrics
Understanding clinical situation and customer use-cases as it applies to critical complaints associated with product clinical use
Performing deep dives or preparing white papers related to clinical risk assessment for product or general areas of clinical practice related to the Business Group
Developing materials related to responses to FDA on field actions, post-market risk assessment and clinical labeling and use of Business Groups products
You are a part of
A fast growing and innovative team, within an ever-changing environment - constantly striving for improvements and exceeding internal and external stakeholder expectations.
To succeed in this role, you should have the following skills and experience
Bachelor or Master degree in a technical area (preferably biomedical engineering)
Management and strong leadership skills in a challenging working environment.
8+ years of related experience a medical device or pharma (preferred) or another regulated industry (automotive, aerospace, food)
Management experience in a Quality, Clinical or Regulatory Affairs management
Experience in preferably in post market surveillance, regulatory submission, complaint handling, adverse event reporting
Process improvement capabilities and experience
Strong written and oral communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers)
Ability to successfully balance and prioritize multiple ongoing projects/task
In-depth knowledge of Quality management systems. Proven work experience and knowledge with medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
A market conform salary
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
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 http://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 .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .