Regulatory Affairs Specialist Job at Medline Alpharetta – Apply Now!
The role of a Regulatory Affairs Specialist is crucial in ensuring medical devices meet all global regulatory standards. At Medline, this position offers an exciting opportunity to plan, execute, and maintain regulatory submissions while collaborating with cross-functional teams. If you have a background in life sciences or engineering and are passionate about regulatory compliance, this full-time hybrid role based in Alpharetta, GA could be the perfect next step in your career.
About Medline
Medline Industries, LP is a leading manufacturer and distributor of medical supplies, committed to improving healthcare quality and outcomes worldwide. With a broad portfolio spanning clinical, surgical, and medical devices, Medline supports healthcare providers with innovative products and services. The company values employee growth, offering extensive training, competitive benefits, and opportunities for advancement within a global organization dedicated to healthcare excellence.
Job Summary
Under general supervision, the Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. May review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete short-term department goals.
Regulatory Affairs Specialist Jobย Description
- In support of business priorities, 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 in-formation, 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.
Minimum Job Requirements:
Education
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
Work Experience
- 2 years of experience in medical device regulatory affairs or quality assurance.
Knowledge / Skills / Abilities
- 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%.
Keywords: Regulatory affairs specialist role, Medical device regulatory affairs job, Regulatory compliance specialist, Medical device regulatory specialist, Regulatory affairs associate. Regulatory Affairs Specialist Job at Medline Alpharetta – Apply Now!
