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Center Valley, PA - The Associate Global General Counsel, Regulatory Law position reports to the Global General Counsel ("GC") and supports primarily the Medical and Surgical businesses of Olympus Corporation and its subsidiaries worldwide on a wide variety of health care related regulatory and quality matters. This position is responsible for providing legal advice to Olympus affiliates in the Americas and supporting 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. (This position is responsible for oversight of health care related regulatory compliance in multiple jurisdictions across the Americas, as well as other regional business centers in Europe, China/Asia Pacific and Japan.
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
At Olympus, we are True to You!
* 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.. - When necessary and appropriate, 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.
* Perform all other responsibilities as appropriate and consistent with position.
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
* J.D. degree from an accredited law school is required. Licensed to practice law in the U.S. is required.
* Minimum of 8 years experience in U.S. healthcare law and regulation, including: Health Care Compliance and Anti-Kickback laws, is required.
* Must possess 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.
* Demonstrated 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.
* Must travel approximately 50%.
* U.S. Food & Drug Administration relationship and equivalent competent authorities globally is desired.
* Medical Device Manufacturing Association relationship is preferred.
* Key Internal relationships that are desired, include: RA/QA personnel of OCA and each of its subsidiaries, OCA Compliance Department, OCA Management, OCA Legal Department, and OCA Human Resources.
* Must be able to stand/sit/walk for 8 hours a day.
Internal Number: 3158BR
About Olympus Corporation of America
Olympus Corporation of the Americas, with headquarters in Center Valley, PA is a precision technology leader, creating innovative opto-digital solutions in health care, life science and consumer electronics products throughout North America. Olympus works collaboratively with its customers and its affiliates worldwide to leverage R&D investment in precision technology and manufacturing processes across diverse business lines. These include: gastrointestinal endoscopes, accessories, and minimally invasive surgical products; advanced clinical and research microscopes, digital cameras and voice recorders.