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PP
Planet Pharma Group
Regulatory Specialist Sr
Career Insights for Regulatory Affairs Specialist
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Based on California data
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What they do
A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
$105,184 / year median in California
+1% projected growth
Job Description
Exempt/Non Exempt:
Non Exempt Years Experience:
Must have 7 years of experiences in Medical Device Regulatory Affairs- Considered as highly experienced with regulatory change assessments.
- Working knowledge in US Medical Device Submissions
- Participates in some of the following: continuous improvement activities, product plan development and implementation, regulatory strategy, risk management, regulatory policy and intelligence.
- Ensures timely approval of new medical devices and continued approval of marketed products.
- Serves as regulatory representative to cross-functional teams.
- Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.