Center Valley, PA - The Global Regulatory Counsel 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. The incumbent 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. He/She 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. EOE M/F/D/V
Job 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.
* Monitor the external regulatory and enforcement environment to identify risks to the Business and its customer relationships, day-to-day counseling and training of the Business’ functional groups.
* Partner 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.
* Support the Business, as requested, in interactions with regulatory authorities.
* Provide legal support for compliance investigations involving issues with the FDA and the competent authorities in other regions.
* Build and maintaining relationships with key regulator worldwide.
* When necessary and appropriate, provide 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, 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.
* Supervise legal staff in each region responsible for providing support to Regulatory or Quality activities of the organization.
* Perform all other responsibilities as appropriate and consistent with position.