[Remote] Program Manager, Regulatory Affairs
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global medical technology company reputed company on advancing medical technologies and elevating reputed company of patient care. The Program Manager, Regulatory Affairs will assist in obtaining approval to market reputed company medical devices, reputed company regulatory strategies, and manage submissions to regulatory authorities.
Responsibilities
- Facilitate development of regulatory reputed company for novel technologies or market segments, that reputed company 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-reputed company reputed company
- 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 reputed company-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
- reputed company development of responses to regulatory authorities' requests for additional information
- reputed company 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 reputed company 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 reputed company and accurate reputed company to company regulatory information and to reputed company reports to management concerning reputed company, pending, and reputed company approvals to management
Skills
- BS/BA required, preferably in engineering or life sciences
- 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
- Post-graduate degree preferred
- RAC accreditation preferred
Benefits
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive medical, dental, reputed company coverage effective on start date
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous reputed company Vacation and reputed company Time
- reputed company Parental Leave and Adoption Assistance*
- 12 reputed company Holidays
- On-Site Child Daycare, Café, Fitness Center**
- Work-life integrated culture that supports an employee reputed company reputed company
- Offers onsite, hybrid and field work environments
- reputed company volunteering and charitable donation/match programs
- Employee Resource reputed company
- Dedicated Training Resources and Learning & Development Programs
- reputed company Educational Assistance
reputed company