Global Counsel Quality and Regulatory

Job Description

The Global Counsel, Regulatory & Quality position reports to the Global Head of Legal, QARA and supports the medical device business (the “Business”) of Olympus Corporation and its subsidiaries worldwide, including in the Americas, Japan, China, Asia Pacific and Europe/Middle East/Africa, on a wide variety of health care related regulatory and quality matters. Responsibilities and areas of legal counsel will include on a global basis, medical device reporting, quality system regulations, manufacturing activities, product approvals, field corrective actions, recalls, quality assurance agreements, product submissions, premarket activities, as well as marketing and promotion.

Job Duties

• Act as a strategic legal partner to the Business in substantive legal areas involving regulatory and quality compliance. Duties and responsibilities in this role include:

1. a. Partnering with the Business' Regulatory Affairs/Quality Assurance teams to assist and counsel on all aspects of medical device regulations such as early research and development activities, product approvals, commercialization, and life cycle management.
2. b. Assisting with drafting and preparing policies, procedures, product manuals, legal guidance documents, and training materials.
3. c. Supporting the Business in interactions with competent regulatory authorities.
4. d. Monitoring the external regulatory and enforcement environment to identify and mitigate risks to the Business and its customer relationships.
5. e. Assisting the Business in obtaining FDA (or equivalent competent authority) clearance and approval to market products as well as assisting in the compliance with post-market requirements.
6. f. Day-to-day counseling of the Business' functional groups.

• Provide legal support in connection with inspections and investigations by the FDA and competent authorities in other regions. Provide assistance with any related remediation activities performed by Olympus in connection with these inspections and/or investigations.
• Advice and counsel the Business on commercialization matters including but not limited to:

1. a. Identifying and effectively addressing medical device regulatory and quality issues that may arise in marketing and promotion activities of medical devices.
2. b. Providing advice and counsel regarding structuring of advisory panels and speakers' bureaus, among other related initiatives.
3. c. Providing advice and counsel on various sales, marketing and other materials relating to medical device products and disease states.
4. 4. Interacts and works collaboratively with other global/regional assurance and control functions (e.g. Compliance, Internal Audit) on regulatory and quality compliance initiatives.
5. 5. Performs all other duties as may be assigned.

Job Qualifications

Required:

• Juris Doctorate from an accredited law school. Must have active license in good standing to practice law in the US.
• Minimum of 4-6 years’ experience in U.S. healthcare law and regulation, preferably with medical devices.
• Must possess the ability to collaborate with business colleagues to understand their needs as they relate to legal issues.
• Must be comfortable providing clear, ethical, and compliant guidance to individuals that are part of a global QARA organization. 

Preferred:

•  Must possess excellent written and verbal communication skills, including the ability to communicate concisely with clients, to integrate legal and business knowledge and to provide balanced advice regarding regulatory risks.
• Ability to work independently and as part of a team.
• Strong cultural sensitivity and experience working in a global environment with global teams.
• Ability to manage ambiguity and practice situational adaptability.
• Feels comfortable stepping up to address difficult issues, saying what needs to be said.
• Ability to consistently achieve results, even under tough circumstances.
• Ensures accountability on all projects and work activities.
• Actively seeks new ways to grow and be challenged using both formal and informal development channels