Program Manager, Regulatory Affairs

Job Description

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 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 foradditional 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.

Job Quaifications

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