Regulatory Operations Compliance Project Manager at Abbott

Maple Grove, Minnesota, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor's Degree in a related field OR an equivalent combination of education and work experience
Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals)
2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences
Knowledge of domestic and international regulatory guidelines, policies and regulations
Ability to lead functional teams

Responsibilities

Lead procedural updates and emerging regulation implementation working with cross BU/ cross functional teams
Develop new regulatory policies, processes and SOPs
Facilitate procedure implementation
Provide strategic input and technical guidance on regulatory requirements for process decisions
Evaluate regulatory risks of division policies, processes, procedures
Develop and mentor regulatory professionals
Drive change order activities
Create supplemental training materials
Review and follow document quality system structure
Lead team meetings and document meeting minutes
Work on process workflow development teams collaborating with Abbott IT system enhancement teams
Author communications and presentations for upper management

Skills

Project Management

Regulatory Compliance

Regulatory Operations

Compliance Management

Medical Devices

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees