Regulatory Program Manager Health
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Job Location:
San Francisco, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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
About Company
Ask Siri to name the most successful company in the world and it might respond: Apple. And it's not just out of familial pride. Apple consistently ranks highly in profit, revenue, market capitalization, and consumer cachet. In 2018, the company became the first reach a trillion dollar ... View more
