Position: Regulatory Strategist (China)
Location: Remote (would need them to go onsite in China periodically Mid 2026 once the submissions are taking place in 12 months)
Duration: 12+ Months
Hours Per Week: Ad-HOC for the first 12 months (5-15 hours per month) – Will ramp up Mid 2026 as the submissions start
Start Date: July 21st
Job Description:
Client is looking for a Regulatory Strategist consultant with expertise in Implantable Devices (preferably neurovascular – implantable stent, balloon and catheter designs) to advise on testing / planning phases for a China submission (Chinese FDA Market, NMPA Submissions). Class 2 and 3 devices and some clinical trials. This person can be based anywhere in the US but needs to speak Mandarin & Cantonese preferred. It would be very beneficial if this person has Chinese Market connections.
Typical example questions this consultant might be asked throughout the months.
- Do we have to do clinical Trials?
- What would be additional testing required on top of the data required for the FDA?
Required Qualifications:
- Implantable Devices; Mandarin (Language); China NMPA Submissions; FDA Submissions
Preferred Qualifications:
- Neurovascular Devices; Catheter; Stents; Chinese Market connections; Cantonese (Language)
Remote: Regulatory Strategist (China) (237747)
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