Program Manager, Regulatory Affairs - Remote

Job Description:

Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus

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 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. Responsible for development, coordination, preparation and maintenance of US medical device submissions such as Pre-Submissions,510ks, PMAs, IDEs and applicable supplement sand 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 4Device License submissions. Lead development of responses to regulatory authorities’ requests for additional information.
• Where designated, 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.
• Responsible for keeping abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes. May be tasked to formally advise regulatory and business 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.

Job Qualifications

Required:

• BS/BA required, preferably in engineering or life sciences. RAC accreditation or Post-graduate degree preferred.
• Regulatory affairs experience in the Medical Device industry is mandatory (minimum 10 years with BS/BA, or 7 years with MS preferred).
• 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.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• Competitive salaries, annual bonus and 401(k)* with company match

• Comprehensive medical, dental, vision coverage effective on start date

• 24/7 Employee Assistance Program

• Free live and on-demand Wellbeing Programs

• Generous Paid Vacation and Sick Time

• Paid Parental Leave and Adoption Assistance*

• 12 Paid Holidays

• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset

• Offers onsite, hybrid and field work environments

• Paid volunteering and charitable donation/match programs

• Employee Resource Groups

• Dedicated Training Resources and Learning & Development Programs

• Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

The anticipated base pay range for this full-time position working at this location is $104,061.00 - $145,685.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.