Senior Manager, Regulatory Affairs - Med Device
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Location
Los Angeles
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Sector:
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Job type:
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Contact:
Nikita Madan
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Contact email:
n.madan@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
about 1 year ago
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Expiry date:
2020-04-16
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Startdate:
ASAP
The Regulatory Affairs – Medical Device Team is looking for a Senior Manager, Regulatory Affairs, Med Device to develop and implement regulatory strategies and processes for medical devices and combination products.
Key Activities
- Responsible for the creation, implementation and maintenance of global regulatory strategies and plans.
- Direct and/or support global filing activities including team reviews prior to submission
- Review and approve device design control deliverables
- Create and support execution and maintenance of regulatory processes
- Direct internal review of policy for global regulatory guidance and regulations
- Identify and communicate relevant guidance, policies, standards, and regulations
- Create and maintain relationships with internal and external stakeholders
- May be required to perform regulatory review of labeling
- Review regulatory sections in development, quality, and supply agreements
- In charge of hiring and mentoring regulatory staff
Required:
6-8 years of Regulatory Affairs, Life Sciences, Engineering related experience with appropriate degree
Preferred:
- 5-7 years of experience working on United States and international medical device and/or combination product regulations
- 6-8 years of related experience in the medical device or combination product industry
- 1-3 years of direct managerial and/or leadership experience