Regulatory Operations Compliance Project Manager – Medical Devices (On-site)
Category: Regulatory Affairs
Location: Maple Grove, MN or St. Paul, MN, USA
About the Company
Abbott is a global leader in healthcare innovation, dedicated to helping people live healthier and more fulfilling lives. With a diverse portfolio spanning diagnostics, medical devices, nutrition, and branded generic medicines, Abbott supports patients and professionals across more than 160 countries. The organization employs over 114,000 professionals committed to advancing global health.
Why Work at Abbott
Joining Abbott means contributing to impactful work while developing your career within a high-growth, globally recognized organization. Employees enjoy:
Comprehensive career development opportunities across global teams
Competitive medical benefits, with eligibility for free coverage in the Health Investment Plan (HIP) PPO
Industry-leading retirement savings plans with strong employer contributions
Tuition reimbursement and education support programs including Freedom 2 Save and FreeU
Recognition as one of the world’s most admired and inclusive companies, with awards in diversity, leadership, and workplace excellence
Abbott’s Medical Device division delivers innovative technologies designed to improve health outcomes—from glucose monitoring systems to advanced therapies for heart disease, chronic pain, and mobility disorders.
Position Overview
Abbott is seeking an On-site Regulatory Operations Compliance Project Manager to support Global Regulatory Services within the Medical Device Division. This role is responsible for managing global compliance projects focused on regulatory process harmonization and emerging regulatory requirements.
As an individual contributor, you will collaborate with international regulatory affiliates, cross-functional teams, and medical device business units to strengthen compliance frameworks and lead regulatory strategy discussions across the organization.
Key Responsibilities
Lead updates to regulatory processes and procedures
Integrate emerging global regulatory requirements into internal documentation
Develop regulatory policies, SOPs, and process standards
Drive implementation of new regulatory procedures across business units
Provide expert regulatory guidance for process and compliance decisions
Assess regulatory risks associated with division policies and workflows
Mentor and support regulatory professionals
Manage change order activities and documentation
Prepare training materials to support regulatory compliance
Ensure adherence to quality management systems and GDP guidelines
Lead team meetings and maintain structured meeting documentation
Collaborate with IT system teams to support workflow development and process automation
Prepare high-level presentations and communication materials for senior leadership
Required Qualifications
Bachelor’s degree in a relevant field or equivalent education and experience
4+ years of experience in a regulated industry (medical devices, nutritionals, or related)
2–5 years of experience in Regulatory Affairs (preferred) or experience in Quality Assurance, R&D, Scientific Affairs, or Operations
Strong verbal and written communication skills for internal and external regulatory discussions
Knowledge of domestic and international regulatory guidelines and compliance standards
Experience supporting or leading regulatory submissions
Preferred Qualifications
Bachelor’s or advanced degree (Master’s/Ph.D.) in science, engineering, pharmacy, or related field
5+ years of experience in a regulated industry
Certification such as RAC (Regulatory Affairs Certification)
Experience with:
CAPA
Windchill
Procedural writing
Regulatory change assessments
International product registration processes
Advertising and promotional material review
Quality system maintenance
Preparing regulatory justification documents
Proven success managing multiple regulatory or compliance projects
Strong project management and meeting facilitation skills
Experience Required (Summary)
Minimum: 4 years in a regulated industry
Preferred: 2–5 years in Regulatory Affairs specifically
Strong advantage: 5+ years total experience with advanced degree or RAC certification
How to Apply
If you are ready to advance your career in regulatory operations within a globally respected healthcare leader, apply now through Abbott’s career portal.
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