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Global Senior Counsel, Regulatory & Quality (Remote)

Req ID:  5128

Working Location: Nationwide 

 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Global Senior Counsel, Regulatory & Quality position reports to the Global Head of Legal - Regulatory, Quality, Medical & Scientific Affairs and supports primarily the medical device business of Olympus Corporation and its subsidiaries worldwide, including 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 medical device reporting, quality system regulation, manufacturing activities, product approvals, field corrective actions, recalls, quality assurance agreements, product submissions, establishment registration, premarket activities, marketing and promotion, investigation device exemptions, labeling and packaging requirements as well as interactions with competent regulatory authorities worldwide.

Job Duties

* Act as a strategic legal partner to the medical device business (the "Business") in substantive legal areas involving regulatory and quality compliance while serving on a strong team of in-house lawyers. Duties and responsibilities in this role include:

  • Partnering with the Business' Regulatory Affairs/Quality Assurance teams to assist and counsel on all aspects of medical device regulation, compliance and enforcement such as early research and development activities, product approval, commercialization and life cycle management.
  • Assisting with drafting and preparing policies, procedures, product manuals, legal guidance documents, and training materials.
  • Supporting the Business in interactions with competent regulatory authorities.
  • Monitoring the external regulatory and enforcement environment to identify risks to the Business and its customer relationships.
  • 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.
  • Day-to-day counseling of the Business' functional groups.
  • Providing legal support for compliance with investigations and obligations under settlement agreements involving issues with the FDA and competent authorities in other regions.


* Advise and counsel the Business on commercialization matters including but not limited to:

  • Identifying and effectively addressing medical device regulatory and quality issues that may arise in the marketing and promotion of medical devices.
  • 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, marketing and other materials relating to medical device products and disease states.
  • Responding to requests from the regional RA/QA teams for the review of product labeling and liability questions.


* Other responsibilities may include:

  • Providing regulatory advice and counsel on day-to-day transactional and contract needs of the other attorneys who support the Business.
  • Providing litigation support (directly or in conjunction with outside counsel) relating to regulatory matters.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* J.D. degree from an accredited law school is required. Active license to practice law in the U.S. and good standing with the bar is required.

 

* Minimum of 5-8 years’ experience in U.S. healthcare law and regulation, preferably with medical devices.

 

* Must possess the ability to collaborate with business leaders to understand their needs as they relate to legal issues.

 

* Must be able to work in partnership with Compliance, Audit and other Legal colleagues. Must be comfortable having to provide clear, ethical and compliant guidance to regional business centers that are part of a global 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.

 

* Demonstrated ability to create, review and work with a wide range of materials including regulatory compliance policies, training materials, product submissions, registrations, labeling, field safety notifications, MDR submissions and proposed promotional materials.

 

* Key internal relationships that are desired include: RA/QA personnel worldwide as well as Olympus’s Compliance and Legal Departments.

 

* Position is remote, with expected travel to Japan, China and EU approximately 10-15%.

 

#LI-KC1

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you. 

 

Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

 

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

 

Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,500 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
 

Olympus…True to You. True to Society. True to LIFE.

 

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 || 


Nearest Major Market: Allentown

Job Segment: QA, Quality Assurance, Outside Sales, Technology, Quality, Sales

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