Olympus Corporation of the Americas Global Counsel Quality and Regulatory in Center Valley, Pennsylvania
Working Location: PENNSYLVANIA, CENTER VALLEY; Nationwide
Workplace Flexibility: Field
Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.
Our Purpose is to make people’s lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View
We deliver on our purpose and our core values by staying True to Life.
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.
- 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:
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.
b. Assisting with drafting and preparing policies, procedures, product manuals, legal guidance documents, and training materials.
c. Supporting the Business in interactions with competent regulatory authorities.
d. Monitoring the external regulatory and enforcement environment to identify and mitigate risks to the Business and its customer relationships.
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.
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:
a. Identifying and effectively addressing medical device regulatory and quality issues that may arise in marketing and promotion activities of medical devices.
b. Providing advice and counsel regarding structuring of advisory panels and speakers' bureaus, among other related initiatives.
c. Providing advice and counsel on various sales, marketing and other materials relating to medical device products and disease states.
- Interacts and works collaboratively with other global/regional assurance and control functions (e.g. Compliance, Internal Audit) on regulatory and quality compliance initiatives.
- Performs all other duties as may be assigned.
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.
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
Why join Olympus?
Here, people matter—our health, our happiness, and our lives.
Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive Medical, Dental, Visions coverage effective on start date
24/7 Employee Assistance Program
Free virtual live and on-demand wellness classes
Work-life balance supportive culture with hybrid and remote roles
12 Paid Holidays
Parental Leave and Adoption Assistance
Volunteering and charitable donation match programs
Diversity & Inclusion Programs including Colleague Affinity Networks
On-Site Child Daycare, Café, Fitness Center**
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks .
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley ||
Olympus Corporation of the Americas
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