Regulatory Operations Professional

2 weeks ago

Saint Paul, Minnesota, United States Abbott Laboratories Full time

Discover a fulfilling career with Abbott Laboratories, a global healthcare leader dedicated to improving people's lives.

About Us

We are a diverse team of professionals working together to develop life-changing technologies that make a meaningful difference in the world. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving over 160 countries.

Career Opportunities

As a Regulatory Operations Specialist at Abbott, you will play a vital role in ensuring our products meet regulatory requirements, maintaining accurate master data, and collaborating with cross-functional teams. Your expertise will be invaluable in resolving issues and driving business growth.

Job Responsibilities

  • Manage Product Release Authorization (PRA) activities, enabling timely shipment of products and achieving departmental objectives.
  • Review and analyze GTS blocked orders, coordinating with stakeholders to resolve issues.
  • Maintain product knowledge, organizing information for internal procedures, reporting, quality plans, and audit needs.
  • Utilize Windchill and other business systems for change control, documentation control, and Regulatory Affairs interactions.
  • Support daily tasks, such as data cleanup, quality system documentation, training, audit support, CAPA, system enhancements, and represent Regulatory Operations in cross-functional interactions.

Requirements

  • Bachelor's or associate degree in a STEM field preferred.
  • At least one year of experience in the Medical Device industry, preferably with ERP and/or PLM systems like SAP and Windchill.
  • Knowledge of Medical Device Quality Management Systems (QMS) and Good Documentation Practice (GDP).
  • Proficiency in MS Office suite (Word, Excel, Outlook).
  • Strong organizational, follow-up, and multitasking skills, with attention to detail and ability to work in a fast-paced environment.

What We Offer

  • A competitive salary range of $48,000 - $96,000, depending on location.
  • A comprehensive benefits package, including health insurance, retirement savings plan, tuition reimbursement, and education benefits.
  • A dynamic work environment with opportunities for growth and development.

EEO Employer

Abbott Laboratories is an Equal Opportunity Employer, committed to diversity and inclusion. We welcome applications from qualified candidates who share our values and vision.

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