Manager of Regulatory Affairs
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Location
San Francisco, CA
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Sector:
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Job type:
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Salary:
Competitive
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Contact:
Cortland Hotz
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Contact email:
c.hotz@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
11 months ago
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Expiry date:
2020-08-05
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Startdate:
ASAP
Class 3 Medical Device Company!
Prepares Regulatory documentation in for product approval in US and International markets.
Support Regulatory risk identification and reduction strategy for pre- and post-market products.
This role with include components of Quality Compliance, QSR/GMP support, vigilance and post-market surveillance activities.
Communicate with International Distributors.
Work cross functionally between internal departments and external consultants to support Regulatory submissions - primary internal expert on preclinical testing of products.
Manages Company’s Explant/Retrieval Analysis program.
Responsible for educating internal team members.
Manages Company’s (PMCF) and (CER).