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Regulatory Affairs Specialist
| Company | Medline |
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| Location | Alpharetta, GA, USA |
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| Salary | $72280 – $105040 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Junior, Mid Level |
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Requirements
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
- 2 years of experience in medical device regulatory affairs or quality assurance
- Understanding of the current Regulatory environment and demonstrating the ability to perform within
- Applied knowledge of FDA regulations and guidelines
- Ability to evaluate information to determine compliance with standards, laws, and regulations
- Travel required up to 5%
Responsibilities
- Determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s)
- Communicate requirements of regulations to internal or external customers
- Recommend regulatory pathways and strategies
- Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met
- Complete and maintain regulatory filings by collaborating with internal and external groups, evaluating supporting technical information, writing appropriate summary documentation, and supporting the response to non-conformances and questions from regulators
- Participate in the development, review, and substantiation of product labeling and claims
- Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert
Preferred Qualifications
No preferred qualifications provided.
