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Rangam Consultants Inc.

Regulatory Affairs Specialist

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What they do

A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.

$97,974 / year median in Minnesota

+1% projected growth

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Job Description

Regulatory Affairs Specialist Rangam Consultants Inc.•3.6 Saint Paul, MN Job Details Contract $32•$40 an hour 1 day ago Qualifications SAP Bachelor's degree
Full Job Description Regulatory Affairs Specialist Job Details Job Type:
1
Year Contract Schedule:
Hybrid•4 days onsite, 1 day remote (Fridays are typically remote but flexibility is available)
Work Location:
Saint Paul, MN Pay Range:
$32/hr•$40/hr (Depending on Experience)
Department:
Research & Development•
Regulatory Affairs Work Environment:
Hybrid office environment supporting global regulatory operations. We are seeking a Regulatory Affairs Specialist to support U.S. product registrations and regulatory compliance for a portfolio of medical devices, cosmetics, and related products. This contract opportunity offers the chance to collaborate with global regulatory teams, maintain regulatory documentation, and support product registrations in a fast-paced research and development environment. Candidates with Medical Device Regulatory Affairs experience are strongly preferred , although professionals with cosmetics or general regulatory affairs experience are encouraged to apply. Responsibilities Support U.S. product registrations and re-registrations for medical devices, cosmetics, and related products. Prepare, review, and maintain regulatory documentation and electronic records. Process regulatory submissions and prepare hard-copy submissions for countries requiring paper documentation. Collaborate with global Regulatory Affairs teams to ensure timely product registrations and regulatory compliance. Support Unique Device Identification (UDI) database maintenance and regulatory data management. Assist with regulatory trade compliance activities. Coordinate document notarization, apostille, and authentication processes as required. Utilize SAP, regulatory databases, UDI systems, and other electronic systems to manage regulatory information. Communicate effectively with internal stakeholders and global cross-functional teams. Qualifications Bachelor's degree or higher from an accredited institution required. 1-2+ years of Regulatory Affairs experience required. Experience supporting medical device regulatory activities is strongly preferred. Regulatory Affairs experience in cosmetics or other regulated industries will also be considered. Experience with SAP, regulatory databases, UDI systems, or similar electronic data management systems preferred. Strong organizational, communication, and collaboration skills. Ability to manage multiple projects while maintaining accuracy and attention to detail. Preferred Qualifications Regulatory Affairs Certification (RAC) preferred. Advanced degree in a scientific discipline. Experience with regulatory strategy and product registration activities. Experience working in a regulated medical device or healthcare environment.
Pay:
$32.00•$40.00 per hour
Work Location:
In person