• Regulatory Affairs Specialist

    Robert Half Office Team (St. Paul, MN)


    Description

    We are looking for an experienced Senior Consultant with expertise in Regulatory Affairs to join our team in St. Paul, Minnesota. This position involves coordinating and preparing documentation for regulatory submissions while ensuring compliance with industry standards. As a long-term contract role, it offers the opportunity to contribute meaningfully to regulatory processes and support the development of healthcare products.

    Primary Responsibilities

    + Track the status and progress of all regulatory documentation.

    + Review, edit, and proofread regulatory documents for accuracy and compliance.

    + Assist in the preparation and review of labeling, SOPs, and other departmental materials.

    + Compile regulatory documents and submission packages under supervision.

    + Prepare and compile responses to regulatory authority questions.

    + Maintain regulatory files in formats compliant with internal and external requirements.

    + Participate as an active member of cross-functional project teams.

    + Stay current on regulatory requirements and updates impacting submissions.

    + May manage a specific product portfolio within the assigned region.

     

    Requirements • Bachelor’s degree in engineering or a related scientific field is required.

     

    • 2-4 years of experience in regulatory affairs, preferably within the healthcare industry.

    • Strong written and verbal communication skills to draft and present regulatory documentation.

    • Proficiency in technical systems, including word processing, spreadsheets, and databases.

    • Ability to prioritize tasks and manage multiple projects effectively.

    • Familiarity with regulatory guidelines and procedures is essential.

    • Detail-oriented with excellent proofreading and editing abilities.

    • Experience in collaborating with cross-functional teams and contributing to project success. TalentMatch®

     

    Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.

     

    Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more.

     

    All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

     

    • 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use (https://www.roberthalf.com/us/en/terms) .