Program Manager, Regulatory Affairs

Working

Location:

Minnesota, Brooklyn Park;
Massachusetts, Westborough;
Nationwide;
Pennsylvania, Center Valley;
Washington, Redmond

Workplace Flexibility:
Hybrid

For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling.

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our

Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus:

Assist 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 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 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.
• 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.
• 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 orchanges to other OSTA staff.
• Responsible for maintenance of regulatory files and tracking databases toensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management.

• 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.
• Experience in collaboration and working with the Regulatory Authorities directly is mandatory.

• 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**

* US Only

• 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

The anticipated base pay range for this full-time position in this location is $ - $ / 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.

At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis