Regulatory Engineering Program Manager
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
The Program Managers responsibilities include providing comprehensive support for regulatory and quality activities in China and the APAC region. This includes product submissions market initiatives and policy interactions.- Oversee regulatory submissions launch readiness design changes and medical device policy activities for the portfolio- Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside cross-functional partners- Communicate program status and escalate risks to a variety of stakeholders- Establish and manage Design History File documentation timelines and successful execution across multiple cross-functional stakeholders
- 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 track record of driving regulatory submissions and quality system implementations with multi-disciplinary teams
- Outstanding communication and organizational skills. Ability to optimally manage multiple projects simultaneously
- 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
- Fluent in Mandarin
- May require travel
- 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
- Solid understanding of regulatory process for different classes of medical devices in China and other international jurisdictions
- Proven track record of driving clinical activities and regulator engagements
- Experience with implementation of tools and systems for process management
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
