Senior Regulatory Counsel, Medical Device

The Senior Counsel for FDA and Global  Health Authority Regulatory Affairs provides to the company’s Medical Devices business general legal counsel to all aspects of the organization regarding the development and execution of various programs, as well as otherwise conducting business operations in conformance with applicable regulatory and health-care related laws and FDA regulations.

• The position advises and consults with stakeholders and project managers, including providing education regarding proactive measures and approaches for executing strategies and tactics in compliance with FDA regulations.  This position will serve as the liaison between the business leaders of the company’s Medical Devices business and all the regulatory attorneys within the company’s Legal Department supporting that business.
• The position updates the relevant organizational leaders on regulatory developments and communicates new developments to the affected business units within the company. The ultimate responsibility of this position is to facilitate the business objectives of the Company by providing timely and effective legal support, as well as minimizing potential legal exposure and risk.
• This position is responsible for rendering practical, timely, and high quality legal counsel and guidance to all aspects of the Medical Device business, including Regulatory, Sales and Marketing, R&D, and Medical Affairs.
• The position works closely with the independent Corporate Compliance Department to ensure compliance with regard to applicable laws and FDA regulations.
• One of the specific responsibilities is to provide counsel on the development, maintenance, and distribution of promotional and other materials used in connection with the sale and promotion of the Company’smedical devices.
• The position is responsible for ensuring that FDA-approved prescribing information for company  products, FDA regulations, and other regulatory best practices are reflected in the Company’s business activities.
• The position also manages outside counsel regarding appropriate marketing and promotion of company products in foreign countries.The position reports to the Vice President, Assistant General Counsel – Regulatory.

Required Experience

Desired Experience