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ProfileAssociate Global General Counsel, Regulatory Law Duties: Act as strategic legal partner to management and the Medical and Surgical business (the “Business”) in substantive legal areas on issues of government policy and enforcement and in the regulatory compliance area while serving on a strong team of in-house lawyers. Duties and responsibilities in this role include: Monitoring the external regulatory and enforcement environment to identify risks to the Business and its customer relationships, day-today counseling and training of the Business’ functional groups. Partnering with the Business’ RA/QA team to assist and counsel in the development of policies, procedures, product manuals, legal guidance documents, tools and training materials. Supporting the Business, as requested, in interactions with regulatory authorities. Providing legal support for compliance investigations involving issues with the FDA and the competent authorities in other regions. Building and maintaining relationships with key regulator worldwide. Providing litigation support (directly or in conjunction with outside counsel) relating to regulatory matters. Provide legal advice to Olympus affiliates in the Americas and supports OEKG, OCAP and OT on regulatory issues including establishment registration, medical device listing, premarket notification, premarket approval, investigation device exemption, humanitarian device exemption, quality system regulation, labeling and packaging requirements, and medical device reporting. Advise and counsel the Business on marketing and promotional matters, including but not limited to: Providing advice and counsel regarding continuing medical education activities, structuring of advisory panels and speakers’ bureaus, among other initiatives. Providing advice and counsel on various sales and marketing and other materials for dissemination relating to potential products and disease states, as well as responding to requests from the regional RA/QA teams for the review of product labeling and liability questions. Providing advice and counsel on day-to-day transactional and contract needs of the other attorneys who support the Business. Identifying and effectively addressing medical device regulatory and quality issues that may arise in the marketing and promotion of business transactions. Assisting the Business in obtaining the FDA (or equivalent competent authority) clearance and approval to market products as well as assisting in the compliance with the post-market requirements. Work with RA/QA on any updates to the Medical Device Reporting (MDR) database. Lead effort to standardize regulatory legal processes in keeping with best practice. Where appropriate, this position may delegate certain duties and responsibilities; however, this role must retain ultimate responsibility for each duty and process/protocol, and must supervise any delegated task.
Qualification and Experience
Requirements: JD Degree from an accredited law school is required. Licensed to practice law in the U.S. is required. 8+ years’ experience in U.S. healthcare law and regulation, including: Health Care Compliance and Anti-Kickback laws, is required. Must have the ability to partner with business leaders to understand their needs as they relate to legal counsel. Must be comfortable with having to provide clear ethical and compliant guidance in all aspects of work to a regional business center that is part of a global organization. Must possess excellent written and verbal communication skills, including the ability to communicate concisely to clients, to integrate legal and business knowledge and to provide balanced advice regarding regulatory risks. Ability to create, review and work with a wide range of materials, including regulatory compliance policies, training materials, product labeling, grant proposals, and proposed promotional materials, are essential.
Auto Req ID: 3158BR
3500 Corporate Pkwy
Center Valley, PA 18034