Regulatory Affairs Program Manager Job Details | Olympus Corporation of the Americas

Full-time - Mid Level

Westborough, MA

5,001-10,000 employees

Merchant Wholesalers, Durable Goods

About the position

Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus. The role involves facilitating the development of regulatory strategy for novel technologies or market segments, leading to product teams responsible for developing new products. The position also includes assisting with Business Development opportunities, including due diligence assessments of regulatory posture, research, and capabilities.

Responsibilities

• Facilitate development of regulatory strategy for novel technologies or market segments.
• Assist with Business Development opportunities, including due diligence assessments of regulatory posture.
• Review and approve product labeling (including IFU) and other ancillary labeling-related matters.
• Work closely with Upstream Marketing and the Regulatory Labeling Team in developing labeling materials.
• Develop, coordinate, prepare and maintain US medical device submissions such as Pre-Submissions, 510ks, PMAs, IDEs and applicable supplements.
• Liaise with FDA reviewers as needed.
• Develop, coordinate, prepare and maintain 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.
• 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 products and processes.
• 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.

Requirements

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

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.