Program Manager, Regulatory Affairs

Working Location

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

Workplace Flexibility

Hybrid

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.
• Assist with Business Development opportunities, including due diligence assessments of regulatory posture, research, and capabilities.
• 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.
• Development, coordination, preparation and maintenance of US medical device submissions such as Pre‑Submissions, 510(k)s, PMAs, IDEs and applicable supplements and annual reports and liaise with FDA reviewers as needed.
• For Canadian Class 2, 3 or 4 Device License submissions, prepare and maintain 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.
• Keep abreast of changes and proposed changes to worldwide regulatory requirements related to our products and processes.
• Formally advise regulatory and business management of changes and communicate regulatory initiatives or changes to other OSTA staff.
• Maintain regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and provide reports to management concerning current, pending, and future approvals.

Job Qualifications

• BS/BA required, preferably in engineering or life sciences. RAC accreditation or post‑graduate degree preferred.
• Regulatory affairs experience in the Medical Device industry mandatory (minimum 10 years with BS/BA, or 7 years with MS preferred).
• Experience writing US and EU submissions mandatory.
• Experience collaborating and working directly with the Regulatory Authorities mandatory.

Benefits

• 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.

Equal Employment Opportunity Statement

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, citizenship status, religious creed, age, sex, gender identity and expression, sexual orientation, marital status, disability, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Applicants Requesting Accommodations

Olympus is committed to the full inclusion of all qualified individuals. If a reasonable accommodation is needed, please contact or call 1‑888‑659‑6787.