Regulatory Affairs Operations Specialist I (on-site)

Abbott Laboratories • Saint Paul, MN

402d • $48,000 - $96,000

About The Position

The Regulatory Affairs Operations Specialist I will be responsible for ensuring compliance with regulatory agency specifications for product registration and market entry. This role involves preparing documentation, managing licenses, and supporting product releases in a fast-paced environment at Abbott's St. Paul, MN location.

Requirements

• Bachelor's Degree or equivalent combination of education or work experience.
• Ability to work in a matrixed and geographically diverse environment.
• Strong verbal and written communication skills.
• Ability to multitask, prioritize, and meet deadlines.
• Strong organizational skills and attention to detail.

Nice To Haves

• Bachelor's Degree in a technical discipline.
• Experience in the medical device industry.
• Experience in a cross-division business unit model.
• Strong problem-solving skills and strategic thinking.
• Adaptability to switch priorities and accomplish tasks.

Responsibilities

• Prepare Global Trade Services (GTS) licenses for product shipments to achieve departmental objectives.
• Follow SOPs for managing GTS licenses and regulatory operations activities.
• Support Product and Country Experts in the release of new and modified products globally.
• Act as a regulatory representative for review and analysis of GTS blocked orders.
• Review customer service requests and maintain high service levels in communications.
• Ensure communications adhere to regulatory standards and convey necessary details.
• Maintain positive communications with employees, customers, contractors, and vendors worldwide.
• Utilize Windchill and SAP applications for research and analysis of blocked orders.
• Represent Regulatory Operations in cross-functional interactions with various departments.
• Support business segment initiatives in compliance with Quality Management Systems and regulatory requirements.

Benefits

• Career development opportunities.
• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan.
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement and student debt programs.
• Recognition as a great place to work and for diversity.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees