Regulatory Affairs Specialist II - Electrophysiology (on-site)

Job Title Regulatory Affairs Specialist II Location Plymouth, MN, United States Job Family Regulatory Operations – EP Electrophysiology Division Job Details Base pay: $61,300.00 – $122,700.00 Work shift: Standard Travel: Yes, 5% of the time Medical surveillance: No Significant work activities: awkward/forceful/repetitive motions, continuous sitting for prolonged periods Responsibilities Authoring and submitting US PMA supplements (30‑day Notice, Real‑Time Reviews, 180‑Day Supplements, Annual Reports), 510(k)s and EU change notifications. Reviewing and approving engineering study protocols/reports and validation study protocols/reports. Reviewing and approving manufacturing changes for ClassIII implantable medical devices. Supporting regulatory projects by processing quality documentation and performing regulatory assessments. Ensuring integrity, accuracy, consistency, and completeness of assigned documentation and deliverables. Communicating with cross‑functional teams—including Program Management, Quality Engineering, R&D, and Supply Chain—regarding inquiries and documentation requirements in alignment with regulatory standards to ensure seamless execution of tasks. Participating in program strategy and contributing to process improvements. Completing additional projects as assigned by management while maintaining compliance with applicable regulations. Performing other related duties and responsibilities as assigned. Required Qualifications Bachelor’s degree (or equivalent). 2‑3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Experience or background in regulatory affairs preferred; quality assurance, research and development/support, scientific affairs, operations, or related areas also considered. Ability to work within a team environment and accomplish projects in a fast‑paced, matrixed environment. Strong verbal and written communication skills; ability to effectively communicate at multiple levels in the organization. Preferred Qualifications Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields. Master’s degree in Regulatory Affairs. Strong attention to detail and ability to work independently as well as collaboratively within teams. Proficiency in Microsoft Office (Word, Excel, PowerPoint), Adobe Acrobat, and SharePoint. Certification is a plus (e.g., RAC from the Regulatory Affairs Professionals Society). Equal Opportunity and EEO Statement Abbott is an Equal Opportunity Employer, committed to employee diversity. Abbott welcomes and encourages diversity in our workforce and is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. #J-18808-Ljbffr