Abbott – Regulatory Affairs Specialist II
Location: Plymouth, MN
Base Pay: $60,000 – $120,000 (may vary by location)
About Abbott
Abbott is a global healthcare leader dedicated to helping people live more fully at every stage of life. Our life-changing technologies span diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues serving over 160 countries, we are committed to improving health worldwide.
Why Work at Abbott?
At Abbott, you can:
Make meaningful contributions that impact lives.
Grow your career with an international organization.
Access free medical coverage through the Health Investment Plan (HIP) PPO.
Benefit from excellent retirement savings plans with high employer contributions.
Utilize tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefits.
Work for a globally recognized company admired for diversity, inclusion, and employee satisfaction.
Join our Electrophysiology (EP) business, advancing treatment for heart disease and atrial fibrillation.
The Opportunity
Abbott is seeking a Regulatory Affairs Specialist II to join our Plymouth, MN team. You will perform specialized work in regulatory documentation, ensuring products comply with domestic and international regulatory requirements. You will support regulatory activities necessary for product market entry.
Key Responsibilities
Prepare regulatory submissions for Electrophysiology devices to meet departmental and organizational objectives.
Review and approve engineering change orders for protocols, reports, specifications, and project documentation.
Act as a regulatory representative by reviewing and analyzing applicable guidelines.
Evaluate communications to ensure adherence to FDA and international regulatory standards.
Maintain up-to-date knowledge of domestic and international medical device regulations and ensure information is distributed to relevant personnel.
Support product release processes in collaboration with the Regulatory Operations team.
Interface with FDA and other regulatory agencies when required.
Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory initiatives.
Comply with FDA regulations, international regulations, company policies, and operating procedures.
Maintain positive, cooperative communication with all levels of employees, customers, contractors, and vendors.
Perform other related duties as assigned.
Required Qualifications
Bachelor’s degree (or equivalent).
2–3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory experience preferred but experience in QA, R&D, scientific affairs, operations, or related areas may be considered.
Ability to work in a team-oriented, fast-paced, matrixed environment.
Strong verbal and written communication skills.
Preferred Qualifications
Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields.
Master’s degree in Regulatory Affairs.
Regulatory experience with capital equipment, including software, firmware, GUIs, and associated hardware.
RAC certification (Regulatory Affairs Professionals Society) is a plus.
Benefits
Comprehensive health and wellness programs
Retirement savings plans with significant employer contributions
Tuition reimbursement, student debt programs, and affordable paths to higher education
Work-life balance, diversity, and inclusion initiatives
Learn more: www.abbottbenefits.com
Equal Opportunity Employer
Abbott is committed to diversity and inclusion in the workplace.
Connect with us:
Website: www.abbott.com
Facebook: facebook.com/Abbott
Twitter: @AbbottNews
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