Senior Counsel Regulatory

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Senior Counsel, Regulatory
Responsibilities: Responsible for counseling on FDA laws, regulations, and guidance documents with respect to complex regulatory issues relating to the development, approval, and marketing of diagnostic testing products and medical devices; product cybersecurity; lifecycle management; as well as inspectional and product safety/quality issues. Collaborates with cross-functional teams and counsels a variety of clients across **MEMBERS ONLY**SIGN UP NOW***.’s medical device businesses on moderately complex legal regulatory issues, such as: product design and validation, product submissions, product field actions, patient complaints, agency inspections, advertising and promotion, and manufacturing requirements; Resolves routine and moderately complex to complex legal regulatory matters with minimal supervision; Keeps abreast of changes in laws and regulations that may impact the regulation of **MEMBERS ONLY**SIGN UP NOW***.’s product offerings and identifies opportunities to influence content and engages in external influencing efforts; Interacts and provides legal and strategic guidance to senior management and functional organizational leadership; Helps select and directs the work of outside counsel, defines project objectives and manages project to ensure the work, strategy and costs meet **MEMBERS ONLY**SIGN UP NOW***.’s expectations; and Conducts regulatory due diligence in connection with potential M&A or other business transactions. Advises multiple **MEMBERS ONLY**SIGN UP NOW***. businesses on legal regulatory matters. Advises Managers, Directors, General Managers, Division Vice Presidents and executive leaders. Advises legal department managers of significant project developments and complex legal issues. Helps manage departmental budget, working with Divisional Vice President and other regulatory attorneys.

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