Regulatory Affairs Specialist II – Medical Devices (On-site)
Location: St. Paul, MN or Santa Clara, CA
Company: Abbott Laboratories – Ventures Division
Work Mode: On-site
Job Type: Full-Time
Salary Range: $60,000 – $120,000 (location-dependent)
Job Summary
Abbott is hiring a Regulatory Affairs Specialist II to support regulatory activities for a transcatheter heart valve replacement device. Based at either St. Paul, MN or Santa Clara, CA, this role supports regulatory submissions, clinical trial approvals, product releases, and compliance efforts. You will ensure adherence to FDA, EU MDR, and global medical device regulations. Ideal for professionals with experience in 510(k), PMA, IDE supplements, and international device submissions.
Key Responsibilities
Prepare and submit regulatory applications to FDA and international agencies
Review engineering changes and product labeling for compliance
Act as a core regulatory member on product and clinical teams
Ensure ongoing updates to regulatory submission databases and documentation
Monitor and interpret changing medical device regulations worldwide
Maintain communication with regulatory agencies and internal stakeholders
Approve GTS licenses and support product release processes
Review protocols and reports for regulatory submission accuracy
Comply with QMS, EMS, FDA, and international regulatory standards
Participate in cross-functional initiatives supporting global compliance
Required Skills & Qualifications
Bachelor’s degree or equivalent combination of education and experience
Minimum 3 years of relevant industry experience, including 2+ years in regulatory affairs
Experience with 510(k), IDE, PMA, and international submissions
Knowledge of FDA and EU medical device regulations
Strong problem-solving, analytical, and communication skills
Ability to manage multiple priorities in a dynamic environment
Detail-oriented with strong documentation and organizational skills
Preferred Qualifications
Bachelor’s or Master’s in life sciences, engineering, or a technical field
Clinical trial regulatory experience
Medical device industry background
Regulatory Affairs Professionals Society (RAPS) certification
Cross-division enterprise experience is an advantage
Perks & Benefits
Base pay between $60,000 – $120,000
Free HIP PPO medical coverage eligibility
Generous retirement savings plan with employer contributions
Tuition reimbursement & FreeU degree support
Freedom 2 Save student debt program
Career development with a global medical leader
Recognized for diversity, innovation, and workplace excellence
Company Description
Abbott is a global healthcare leader with a diverse portfolio across diagnostics, medical devices, nutrition, and branded generics. With operations in over 160 countries, Abbott innovates life-changing technologies that empower people to live healthier, fuller lives. The company is a leader in regulatory excellence, compliance, and medical innovation.
Work Mode
On-site – St. Paul, MN or Santa Clara, CA
Call to Action
Drive global compliance and innovation in the medical device industry. Apply now to join Abbott's regulatory affairs team and make an impact in healthcare worldwide.
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