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Regulatory Affairs Manager
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$1 - $2
- The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide.
- Responsibilities Plans and prepares regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports with moderate supervision.
- Responsible for regulatory review of labels, labeling, advertising and promotional materials.
- Collaborate with Regulatory Operations to compile and review regulatory submissions for completeness and quality.
- Identify and draft necessary SOPs and/or Working Practices for Regulatory Affairs Qualifications Minimum of Bachelor’s degree.
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