Regulatory Affairs Program Manager
Company: Olympus Corporation of the Americas
Posted on: May 6, 2022
Working Location: Washington, Seattle; NationwideAre 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 DescriptionRegulatory
Affairs Program Manager will support the organization in obtaining
and maintaining market approval of Olympus medical devices in the
markets served by Olympus.This position is intended to operate
fully remote.Job Duties
- Facilitate development of regulatory strategy for novel
technologies or market segments, that lead to product teams
responsible for developing new products.
- Where tasked by Regulatory Management, assist with Business
Development opportunities, including due diligence assessments of
regulatory posture, research, and capabilities.
- Responsible for development, coordination, preparation, and
maintenance of US medical device submissions such as
Pre-Submissions, 510ks, PMAs, IDEs and applicable supplements and
annual reports and liaise with FDA reviewers as needed.
- Where designated, responsible for development, coordination,
preparation, and maintenance of medical device submissions for
Canadian Class 2, 3 or 4 Device License submissions and EU class
1s, IIa, IIb, orIII medical devices under Regulation (EU) 2017/745.
- Lead development of responses to regulatory authorities'
requests for additional information. Interface with International
Regulatory Affairs Team to support preparation of dossiers for
registration for other international markets such as Japan, the Far
East, Australia, and Latin America.
- Keep abreast of changes and proposed changes to the worldwide
regulatory requirements related to our products and processes. May
be tasked to advise management of changes, and as appropriate,
communicate regulatory initiatives or changes to other OSTA Staff.
- Responsible for maintenance of regulatory files and tracking
databases to ensure prompt and accurate access to company
regulatory information and to provide reports to management
concerning current, pending, and future approvals to management.
- Where designated, review and provide input to clinical related
documentation, including clinical investigational plans,
investigator brochures, informed consent, instructions for use, and
case report forms.Job RequirementsREQUIRED QUALIFICATIONS:
- Bachelor's degree equivalent degree in science, engineering, or
- Minimum of 10 years working in medical device industry.
- Minimum of 7 years progressively responsible experience working
on US/EU medical device submissions
- Direct experience working and collaborating with Regulatory
- High level of proficiency in Microsoft Word, Outlook, Excel and
- RAC, CQA, and CQM accreditation preferred.
- Science or engineering course of study optimal.
- Knowledge of FDA medical device regulations and guidance,
Medical Device Regulation (EU) 2017/745, ISO 13485 Quality System
standard, and other applicable US and international regulations,
guidances, and standards.
- Proven expertise with regulatory submissions: 510(k), IDE
and/or PMA submissions, and submissions outside the US, including
- Visio skills are desirable.We realize work isn't just a job to
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) -- Washington (US-WA) --
Keywords: Olympus Corporation of the Americas, Redmond , Regulatory Affairs Program Manager, Executive , Redmond, Washington
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