Regulatory Operations Specialist I

2 days ago


Saint Paul, Minnesota, United States Abbott Laboratories Full time

Abbott Laboratories is a leading healthcare company that offers diverse opportunities for growth and development. Our team of professionals works together to deliver innovative solutions that improve people's lives.

We are seeking a Regulatory Operations Specialist I to join our St. Paul, MN location. As a member of our team, you will be responsible for performing specialized level work assignments and analyses, evaluation, preparation, and general support of global regulatory activities.

The ideal candidate will have a bachelor's or associate degree in a STEM field and related experience in the Medical Device industry. You should also be proficient in ERP and/or PLM systems such as SAP and/or Windchill, and have knowledge of Medical Device Quality Management Systems (QMS) and Good Documentation Practice (GDP).

This role requires strong organizational and follow-up skills, attention to detail, and the ability to multitask, prioritize, and meet deadlines in a timely manner. You should also be able to communicate effectively at multiple levels within the organization and adapt to changing priorities.

In this role, you will maintain a basic understanding of product lines and organize product information for internal procedures, reporting, quality plans, and audit needs. You will also understand and utilize Windchill and other business systems for change control, documentation control, and other Regulatory Affairs interactions.

As a Regulatory Operations Specialist I, you will serve as a regulatory representative, reviewing and analyzing GTS blocked orders, and coordinate activities to resolve issues. You will also represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates, and IT.

We offer a competitive salary range of $48,000-$96,000, depending on location. You will also receive comprehensive benefits, including health insurance, retirement savings plan, tuition reimbursement, and education assistance. Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity.



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