Regulatory Affairs Specialist I – St. Paul, MN (On-site)
Job Summary
Abbott’s Structural Heart division in St. Paul, MN is hiring a Regulatory Affairs Specialist I to support global regulatory activities ensuring compliance in medical device development and market authorization. This position offers an excellent opportunity to contribute to life-saving innovations in structural heart disease while developing expertise in FDA and international regulatory procedures within a world-class healthcare organization.
Key Responsibilities
Analyze cumulative product changes impacting current regulatory submissions.
Provide solutions to moderately complex regulatory problems.
Prepare and align personal goals with department objectives.
Participate in development and execution of group plans.
Ensure compliance with GMP guidelines and procedures.
Create clear and concise regulatory documentation for various audiences.
Implement and maintain effectiveness of the quality system.
Advise teams on basic regulatory strategies and processes.
Sign-off authority on change controls within delegated parameters.
Review and approve labeling, sales, and promotional materials.
Draft official correspondence for supervisory review before submission to regulatory bodies.
Engage in negotiations on routine regulatory matters with government agencies.
Support resolution of compliance issues ensuring alignment with site and divisional policies.
Required Skills & Qualifications
Bachelor’s Degree or equivalent combination of education and experience.
Excellent verbal and written communication skills across organizational levels.
Strong organizational skills with attention to detail.
Ability to multitask, prioritize, and meet deadlines in a fast-paced environment.
Ability to work in a matrixed, cross-functional, and geographically diverse team structure.
Preferred Qualifications
Bachelor’s degree in science, engineering, pharmacy, pharmacology, or medical technology fields.
Regulatory Affairs Professionals Society (RAPS) certification preferred.
Strong analytical and problem-solving skills.
Detail-oriented with a passion for compliance and regulatory research.
Perks & Benefits
Salary Range: $50,000 – $100,000 annually.
Free medical coverage under the Health Investment Plan (HIP) PPO.
Exceptional employer-contributed retirement savings plan.
Tuition reimbursement, Freedom 2 Save program, and FreeU education benefit.
Professional development and career advancement in a global healthcare leader.
Company Description
Abbott is a global leader in diagnostics, medical devices, nutrition, and branded pharmaceuticals. With over 114,000 employees across 160+ countries, Abbott’s mission is to deliver innovative healthcare technologies that help people live healthier and fuller lives.
Work Mode
On-site – St. Paul, Minnesota, United States
Call to Action
Take the next step in your regulatory affairs career. Apply now to join Abbott and contribute to life-changing innovations in the field of structural heart devices.
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