Regulatory Program Manager Health

The Program Manager will provide comprehensive support for all global submissions product launches design changes and policy interactions. Responsibilities include : Oversee regulatory submissions launch readiness design changes and medical device policy activities for the medical device portfolio Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside multi-functional partners Communicate program status and escalate risks to a variety of partners Establish and lead Design History File documentation timelines and successful execution across multiple stakeholders This is a site-based role and may require occasional travel.

• Bachelors degree preferably in engineering science business or equivalent field
• 8 years of program / project management experience in a regulated industry preferably in medical products and / or digital health
• Proven understanding of regulatory process for different classes of medical devices in both the US and internationally
• Consistent track record of driving regulatory submissions and launches with multi-disciplinary teams
• Outstanding communication and organizational skills. Ability to efficiently handle multiple projects simultaneously
• Masters degree preferably in engineering science business or equivalent field
• 10 years of program / project management experience in a regulated industry preferably in medical products and / or digital health
• Consistent track record of driving quality system updates and regulator engagements
• Experience with implementation of tools and systems for process management
• Excellent analytical and problem-solving capabilities with a keen eye to detect and mitigate risks
• Independent self-starter who thrives in ambiguous environments
• Hands-on experience in the use of project management and reporting software

Required Experience :

Manager

Key Skills

Project Management Methodology,Project / Program Management,Program Management,Management Experience,Microsoft Powerpoint,Project Management,Microsoft Project,Budgeting,DoD Experience,Leadership Experience,Supervising Experience,Contracts

Employment Type : Full Time

Experience : years

Vacancy : 1