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Regulatory Affairs Specialist
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$76,163 - $101,551 a year
Full-time
- As an individual contributor, the Regulatory Affairs (RA) Specialist acts as a link between the company and regulatory authorities, ensuring that products are distributed in compliance with local regulations.
- The Regulatory Affairs Specialist will be responsible for combining scientific, regulatory, and business issues to enable projects that are developed, manufactured, and distributed to meet local regulations and requirements.
- Evaluates manufacturing changes for impact on North America regulatory affairs approvals, clearances, registrations, and licenses.
- Keeps abreast of regulatory requirements, this includes monitoring FDA and standards.
- Reviews and approves device labeling for compliance with applicable regulations.
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