06 sep Senior Legal Director Regulatory – Global Healthcare
Our client Philips (Healthtech) is a listed multinational with global operations in more than 100 countries worldwide. A company with a focus on both the B2B and the B2C businesses. Innovation and sustainability are keywords for Philips.
On behalf of Philips, we are looking for a Senior Legal Director Regulatory to advise on legislation and regulations regarding medical devices. The Senior Director operates in a leadership position within the Group Legal Department, which operates at the heart of Philips’ 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.
You will have a leading role in advising Philips’ in-house regulatory professionals, legal business partners and management of individual Philips businesses in a wide variety of legal and regulatory matters, such as 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. In managing the management and business support you will work closely with two legal counsel regulatory in the U.S. who will directly report to you.
You will be responsible for:
- Managing the development and implementation 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;
- Coordinating responses to medical device enforcement actions with in-house regulatory professionals and outside counsel, interfacing as necessary with regulators, focusing on FDA and MDR actions and the implications and relevancy of enforcement actions elsewhere;
- Acting as an internal resource for other members of the legal department worldwide on medical device regulation and related matters;
- Supporting legal counsel and business partners in reviewing purchasing, sales, research, and B2B contracts with respect to potential regulatory implications;
- 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.
- Academic Law degree and preferably at least 10 to 15 years experience as a lawyer and/or in-house legal counsel in an international working environment;
- Several years of relevant experience in advising on legal regulatory matters, preferably with a medical device focus;
- Knowledge of EU Medical Device Directive and regulatory regimes in other major markets is a must, knowledge of or affinity with FDA compliance is highly appreciated;
- Solid experience working with client business leaders and regulatory professionals is desirable, whether as in-house counsel or in private practice;
- Managerial experience is highly preferred;
- Comfortable with working in a global matrix organization consisting of attorneys, paralegals, regulatory professionals and business leaders.
Philips welcomes you to a leading role in Legal & Regulatory, in a challenging, innovative global environment at the highest level. Very competitive benefits will be designed around your preferences.