Vice President, Regulatory Affairs

Company: Olympus Corporation of the Americas
Location: Westborough
Posted on: November 19, 2021

Job Description:

Working Location: MASSACHUSETTS, WESTBOROUGH; Nationwide; PENNSYLVANIA, CENTER VALLEY; WASHINGTON, REDMOND
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 purpose of this position is to provide leadership and management to the Regulatory Affairs function in Olympus Corporation of the Americas. This role will be responsible for the global regulatory filings of all products where the Legal Manufacture exists in the Americas region. Further, they will serve as a consulting role for where the Legal Manufacture is an Olympus company that exists outside of the Americas.
Job Duties * Establishing and Executing a Regulatory Strategy for product Manufactured by OSTA and sold WW. Represent Regulatory Affairs on project teams and provides regulatory guidance regarding submission and clearance strategy.

* Act as a consultant for product manufactured by Olympus in other regions but sold in the Americas. Represent Regulatory Affairs on project teams and provides regulatory guidance regarding submission and clearance/approval strategy.

* Authoring and maintaining regulatory filings for product manufactured by OSTA including 510k IDE/PMA and HDE products. Review revise compile submit and clear regulatory submissions for Olympus branded products manufactured outside the U.S.

* Manage the Label Control and Advertising and Promotion review process

* Monitor the Regulatory Environment in the Americas and advice the company on changing regulation in the region. Interpret regulations guidance/policies; communicate existing policies and changes in the regulatory environment to RA staff outside of the Americas.

* Serve as spokesperson for OCA in the Americas region on Regulations either through industry groups or serving on Regulator Advisory Panels.

* Serve as most responsible Quality/Regulatory contact on any Regulatory Mandated Clinical Study.

* Support the Clinical Affairs department for FDA regulated clinical studies assuring that all regulatory submissions and documentation comply with U.S. regulations.

* Demonstrates the ability to form and motivate cross functional groups to accomplish project related objectives.

* Develop the next generation of Quality thought leaders.
Job Requirements REQUIRED QUALIFICATIONS:
* Bachelor's degree required, Master's degree preferred.

* Minimum of 10 years experience in medical device industry.

* Minimum of 5 years experience in a position of leading and developing people leaders and teams.

* Some travel will be required, but no more than 25%.

PREFERRED QUALIFICATIONS:

* Expert understanding in the writing of regulatory submissions.

* Expert understanding in the writing of Tech Files.

* Strong people leader with experience raising the skill level of the organization.

* Ability to work with business partners in other functions to achieve business results.
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 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' 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 overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.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) -- Massachusetts (US-MA) -- Westborough --

Keywords: Olympus Corporation of the Americas, Worcester , Vice President, Regulatory Affairs, Executive , Westborough, Massachusetts