Program Manager, Regulatory Affairs
Program Manager, Regulatory Affairs
Working Location: MASSACHUSETTS, WESTBOROUGH; 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.
Nationwide (with relocation assistance to the greater Westborough, MA area)
- currently fully remote- hybrid work schedule 1-2 days office/3-4 days home by Sept 1
The Principal, Regulatory Affairs assists the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus.
- 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 regulatoryposture, research, and capabilities.
- Maintain responsibility for review and approval of product labeling (including IFU) and other ancillary labeling-related matters.
- Work closely with Upstream Marketing and the Regulatory Labeling Team in developing labeling materials.
- Maintain responsibility 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
- Maintain responsibility for development, coordination, preparation and maintenance of medical device submissions for Canadian Class 2, 3 or 4 Device License submissions.
- Lead development of responses to regulatory authorities’ requests for additional information.
- Interface with the EU Submissions Team to support preparation of dossiers and technical files for registration of Olympus products in the EU 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.
- Maintain responsibility for keeping abreast of changes and proposed changes to the worldwide regulatory requirements related to our products andprocesses.
- May be tasked to formally advise regulatory and business management of changes and as appropriate communicate regulatory initiatives orchanges to other OSTA staff.
- Maintain responsibility for maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatoryinformation and to provide reports to management concerning current, pending, and future approvals to management.
- Perform other duties as assigned.
- Bachelor's degree is required.
Minimum 10 years regulatory affairs experience in the Medical Device industry is required with Bachelor's degree.
- Regulatory affairs experience in writing US submissions and EU submissions is mandatory and experience in collaboration and working with the Regulatory Authorities directly is mandatory.
- Master's degree is preferred.
- Minimum 7 years regulatory affairs experience in the Medical Device industry is preferred with Master's degree.
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, 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 a global technology leader, crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Throughout our 100-year history, Olympus has focused on being true to society and making people’s lives healthier, safer and more fulfilling.
Olympus Canada Inc. (OCI)—a subsidiary of Olympus Corporation of the Americas—manages the Company’s operations and workforce throughout Canada in roles such as sales, marketing, service, and support functions. Based in Richmond Hill, ON, OCI is committed to developing our employees and supporting our local communities. For more information, visit olympuscanada.com and truetolife.com.
Olympus…True To You. True To Society. True To LIFE.
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled