Legal Counsel Regulatory
Job TitleLegal Counsel Regulatory
In this role, you have the opportunity to
Advise in-house regulatory professionals, legal business partners, as well as management of individual Philips businesses in clinical investigations, premarket clearance, marketing and advertising, quality system compliance, adverse event reporting, and related export issues under the US Federal Food & Drug and Cosmetic Act and similar (international) laws and regulations.
You are responsible for
- Supporting and facilitating the development of policies and programs in conjunction with quality & regulatory and business management to facilitate compliance with medical device regulation and law throughout Philips' businesses, as well as analysis of their effective effectiveness in implementation;
- Acting as an internal resource for other members of the legal department worldwide on medical device regulation and related matters;
- Upon request by counsel, reviewing purchasing, sales, research, and B2B contracts with respect to potential regulatory implications;
- Coordinating responses to medical device enforcement actions with in-house regulatory professionals and outside counsel, interfacing as necessary with regulators, focusing on FDA actions and the implications and relevancy of enforcement actions elsewhere by the FDA on Philips interests;
- Reviewing media communications relating to regulated medical devices;
- Supporting the development and delivery of training programs designed for managers and other counsel worldwide to facilitate these activities.
You are a part of
One of Philips' Group Staff Departments, you will be at the heart of our worldwide company. Philips' Legal Department spans a global network of some 170 professionals operating as one integrated, internal law firm for Philips' businesses worldwide advising on all legal matters relevant to Philips. Philips GLD is based in Amsterdam. It covers a number of areas of expertise, in particular Corporate & Financial Law, M&A, and Legal Compliance.
The Group Legal Compliance team consists of senior legal professionals and subject matter experts responsible for compliance topics such as antitrust, export controls, data protection, privacy, healthcare compliance and anti-corruption.
To succeed in this role, you should have the following skills and experience
- More than 10 years' FDA compliance experience, with a medical device focus;
- Experience with working on investigational devices, pre-market submissions, quality systems, device reporting and advertising and promotion;
- Knowledge of EU Medical Device Directive and regulatory regimes in other major markets;
- Solid experience working with client business leaders and regulatory professionals is desirable, whether as in-house counsel or in private practice;
- Comfortable with working in a matrix organization consisting of attorneys, paralegals, regulatory professionals, and business leaders.
In return, we offer you
A challenging, innovative environment with great opportunities for you to explore. Furthermore, our benefits are very competitive and designed around your preferences.
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. 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 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.
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Jose engineers the specific system level requirements for the Philips Sonicare oral healthcare products. He makes certain the detailed design of each device over-delivers on customer expectations every time.
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