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Associate Regulatory Affairs Specialist

3 months ago

Winnetka, Illinois, United States Medline Industries Full time

JOB SUMMARY:
Under direct supervision, responsible for executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare and review documents for regulatory filings for regulatory authorities under general supervision of RA management.

Participate in teams within the department and organization by bringing basic technical skills, critical thinking, and understanding of related regulatory frame-works to meet short-term regulatory goals and business requests.


MAJOR RESPONSIBILITIES:


Investigate federal, state or local licensing requirements through review of laws and regulations or through direct contact with regulatory authorities.

In support of business priorities, determine the requirements for marketing and distributing regulated products
Communicate appropriate regulatory requirements to internal or external customers or vendors where necessary.

Review, identify and assess documentation provided by product managers, vendors, divisional QA's and marketing (internal and external customers) to ensure it meets applicable regulatory requirements.

Interact with internal and external customers to complete the proper licensing, registration, listing, or submission for Medline products and/or facilities.

Partner with team members, internal customers, external suppliers, and consultants to complete assigned regulatory activities.

Education

B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.

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