Medical Device Regulatory Counsel (Andover MA)

Philips HealthcareA leader in Healthcare, Philips Healthcare is one of the world's top three medical device companies. Our mission is to improve the quality of people's lives.Our focus areas include imaging systems, customer services, information and monitoring systems. We enjoy a number one position in several of these including X-ray, cardiovascular ultrasound, patient monitoring and automatic external defibrillators. Our HeartStart Home Defibrillator brings life-saving technology to consumers in their own homes, where the majority of sudden cardiac arrests occur. It's just one of the many ways we deliver 'advanced' technology that is 'designed around you' and 'easy to experience'. The Philips Healthcare Law Department is an integral part of this dynamic organization. Like our products and services, we make a difference. We are dedicated to providing high quality legal services on a timely basis to our colleagues around the world so that we as a company can not only better serve our customers but also the communities we serve and in which we live. We have small legal teams on four campuses in the US; Andover, MA, the worldwide headquarters of Philips Healthcare, Cleveland, OH, Pittsburgh, PA and Seattle, WA. We seek like minded legal professionals to join us in our commitment to service and continuous improvement at several of our campuses. It is the strategy of the Philips Law Department to have lawyers dedicated to a limited number of specific businesses so that they can develop deep insight into the legal, social and political issues affecting them and then after a few years, reassigning them to other businesses within the Healthcare group to leverage that experience in other areas of the business. Our goal is to provide a work environment that continually challenges intellectually and professionally. We are convinced that through a continually expanding perspective, the delivery of legal services within the group will contribute to our corporate goal of helping people live longer, fuller lives in dignity and with respect. Your Responsibilities: This is a multi-tasking corporate legal role reporting to a senior attorney working in a rapidly changing and growing business environment. Working under the supervision of Sr. Regulatory Counsel, the successful candidate will have a core competency in current FDA and worldwide medical device, and/or pharmaceutical regulation to advise in-house regulatory professionals, as well as all levels of Philips management in clinical investigations, premarket clearance, marketing and advertising, quality system compliance, adverse event reporting, and related export issues.- Act as an internal resource for other members of the legal department on device regulation and related matters- Review purchasing, sales, research, and B2B contracts for regulatory implications and compliance.- Coordinate/facilitate corporate and sector tasks when applicable to ensure compliance with Royal Philips and Philips Healthcare policies and directives.- Coordinate response to medical device enforcement actions with in-house regulatory professionals and outside counsel- Coordinate with counsel in other sectors of Royal Philips.- Supervise one or more paraprofessionals who are assisting in performing these and other regulatory compliance functions Your Profile: - 4-7 years of significant, relevant legal experience in a global matrix organization or law firm -JD from an accredited US law school and admission to the bar.- Working knowledge of FDA device regulation. Pharma experience will also be considered.- Experience in consumer law and healthcare law a plus.- Meaningful experience in export control regulations- Comfortable with having to provide clear ethical guidance in all aspects of work to a global organization.- Strategic thinker who can focus on providing the organization added value through efficiency and good business sense.- Collegial, cooperative and an open person who enjoys being a team builder in a rapidly changing environment.- Ability to travel.- Persuasive presentation and counseling skills. Contacts: Philips Notes Philips is an equal opportunity employer.Eligible for an employee referral bonus of 7,500 Simplicity Rewards points. Job ID: 52475 Apply here View all "Philips" jobs Learn more about Philips Send this Job to a Friend