Principal Regulatory Affairs Specialist – Vascular (on-site)
Abbott · New Brighton, MN
RegulatoryFull-time$87k–$173kCompany career page
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Role summary
Abbott seeks a Principal Regulatory Affairs Specialist for its Vascular Division in Minnesota to develop worldwide regulatory strategies and prepare submissions for FDA and international agencies. The role involves coordinating product registrations, representing regulatory affairs on cross-functional teams, and serving as a subject matter expert for compliance and inspections.
What they're looking for
- Bachelor's degree in chemistry, life sciences, biology, or equivalent vocational qualification
- Demonstrated experience with regulatory submissions for pharmaceutical, IVD, or medical devices
- Knowledge of 21 CFR 820, ISO 13485, Medical Devices Directive, and IVD Directive requirements
- Minimum 5 years working with Class II or Class III medical devices
- Experience preparing IDE applications, 510(k) submissions, PMA supplements, or international registrations
- Familiarity with quality systems standards and clinical investigation regulations
- Regulatory Affairs Certification (RAC) preferred
What you'll be doing
- Develop worldwide regulatory approval strategies for new and modified vascular products
- Prepare and submit regulatory applications to FDA and international agencies including IDE, dossiers, and notifications
- Represent regulatory affairs on cross-functional teams and participate in design reviews
- Monitor and analyze global medical device regulations; update submission databases and distribute changes
- Interface directly with regulatory agencies, notified bodies, and in-country affiliates as liaison
Privacy & handoff
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