Regulatory Affairs Speciaist at Medline Industries, Inc. in Northfield, Illinois

Job Description:

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.

Job Description

Responsibilities:

• 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 Qualifications:

• 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.




• 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%.

Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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