Vice President, Regulatory Affairs
Company: Olympus Corporation of the Americas
Posted on: November 19, 2021
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
* 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
* 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%.
* Expert understanding in the writing of regulatory
* Expert understanding in the writing of Tech Files.
* Strong people leader with experience raising the skill level of
* 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
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
Posting Notes: -- United States (US) -- Massachusetts (US-MA) --
Keywords: Olympus Corporation of the Americas, Worcester , Vice President, Regulatory Affairs, Executive , Westborough, Massachusetts
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