Regulatory Affairs Manager

Philips

📍 Suzhou, China, China

Full-time other-general

Job Description

**In this role, you have the opportunity to**
+ Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into the Peoples Republic of China. Communicates with relevant competent authorities, agents, distributors and local sales offices to ensure the most efficient path to application approval.
+ Advise local and international teams on the most expedient route to obtaining product licenses, and ensure market access strategy is aligned with local and international marketing/sales requirements.
+ To resolve any conflicts of strategy with marketing/sales strategies and determine the regulatory impact of such strategy on license approval timescales.
**You are responsible for**
+ Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc.
+ Create detailed written regulatory plans that can be used to target domestic and intern...
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