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Years of Experience
Date Last Verified
ProfileSenior Counsel, Regulatory The candidate will be responsible for counseling on FDA laws, regulations, and guidance documents with respect to complex regulatory issues relating to the development, approval, and marketing of medical devices; product cybersecurity; lifecycle management; as well as inspectional and product safety/quality issues. Duties: Collaborates with cross-functional teams and counsels a variety of clients across company’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 affect the regulation of company’s medical devices, 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 company’s expectations; and Conducts regulatory due diligence in connection with any potential medical device acquisition activities. Advises legal department managers of critical project developments in a timely manner. Executes core job responsibilities in a timely manner. Assigned matters may have a moderate impact on business activities and operations. Advises Managers, Directors, General Managers and Division Vice Presidents. No direct department budget responsibility; must however operate within budget. Develops budgets for assigned legal matters with supervision from more experienced attorneys.
Qualification and Experience
The candidate should have Juris Doctor degree. Generally have 7+ years of experience and demonstrated expertise in providing legal counsel on medical device regulatory and quality matters with a major corporation or law firm; prior cybersecurity expertise or government experience is also beneficial. Must have demonstrated ability to manage attorneys and/or paralegals, and to perform successfully in cross-functional teams, with the ability to lead and mentor. Must have ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment. In addition to top-notch legal skills, must have excellent interpersonal, strategic thinking, communication and organizational skills.
JOB ID: 30873233
15900 Valley View Ct,
Sylmar, CA 91342