Regulatory Affairs Specialist II – Ventures (On-site, Woodridge, MN)
Job Summary
Abbott’s Ventures division in Woodridge, MN is seeking a Regulatory Affairs Specialist II to support regulatory activities for an innovative transcatheter heart valve replacement device. This role involves preparing regulatory applications, overseeing global submission requirements, and ensuring clinical trial operations comply with FDA and international regulations. Ideal for candidates eager to contribute to life-changing medical technology in a globally recognized healthcare leader.
Key Responsibilities
Prepare robust regulatory applications for FDA and international agencies.
Create, review, and approve engineering change requests and device labeling.
Act as the regulatory core team member providing assessments of applicable regulations.
Maintain up-to-date knowledge of U.S. and international medical device regulations.
Ensure global submission requirements are documented in regulatory databases.
Interface with the FDA and other international regulatory agencies as needed.
Support product release by creating GTS licenses and reviewing approval requests.
Review study protocols and reports to support regulatory submissions.
Collaborate with Quality Management Systems (QMS) and Environmental Management Systems (EMS) requirements.
Maintain compliance with FDA, EU, and global regulatory standards.
Required Skills & Qualifications
Bachelor's degree or equivalent combination of education and experience.
Minimum 3 years of related experience with at least 2 years in regulatory affairs.
Experience with FDA 510(k), IDE supplements, PMA supplements, and/or EU medical device submissions.
Strong organizational, problem-solving, and strategic thinking abilities.
Excellent communication skills across multiple organizational levels.
Ability to prioritize, multitask, and meet deadlines in a dynamic environment.
Preferred Qualifications
Bachelor's degree in a Science/Technical discipline (e.g., engineering, life sciences, mathematics).
Master’s degree in a relevant field.
Experience with regulatory activities for clinical trials.
Exposure to enterprise or cross-division business models.
Regulatory Affairs Professionals Society (RAPS) Certification.
Perks & Benefits
Salary Range: $60,000 – $120,000 annually.
Free medical coverage under Health Investment Plan (HIP) PPO.
Excellent employer-contributed retirement savings plan.
Tuition reimbursement, Freedom 2 Save program, and FreeU education benefit.
Career development opportunities in a Fortune-ranked global healthcare leader.
Company Description
Abbott is a global leader in diagnostics, medical devices, nutrition, and branded pharmaceuticals. With over 114,000 employees worldwide, Abbott is committed to developing technologies that help people live healthier, fuller lives.
Work Mode
On-site – Woodridge, Minnesota, United States
Call to Action
Are you ready to drive regulatory excellence in breakthrough cardiovascular technology? Apply now and shape the future of heart valve innovations at Abbott.
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