Regulatory Operations Specialist II at Abbott

Plymouth, Minnesota, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Bachelor’s Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields preferred, or equivalent combination of education and work experience
Master’s Degree preferred
Minimum 2-3 years experience in a regulated industry (e.g., medical products, nutritionals); regulatory area preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
Experience with regulatory history, guidelines, policies, standards, practices, requirements, and precedents; regulatory agency structure, processes, and key personnel; principles and requirements of applicable product laws; submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); principles and requirements of promotion, advertising, and labeling; domestic and international regulatory guidelines, policies, and regulations; ethical guidelines of the regulatory profession, clinical research, and regulatory process (knowledge may be developed through tenure)
Communicate effectively verbally and in writing with diverse audiences and personnel
Write and edit technical documents
Work with cross-functional teams and people from various disciplines and cultures
Negotiate internally
Pay strong attention to detail
Manage projects, create project plans, and timelines
Think analytically and critically

Responsibilities

Provide daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries, and business partners to allow shipment and achieve objectives
Follow SOPs for managing GTS licenses, additional release authorizations (ARAs), tender support, and overall regulatory operations activities
Provide support for Product and Country Experts in the set-up for release of new and modified products globally
Act as regulatory representative for review and analysis of GTS blocked orders, providing guidance and direction on regulatory compliance
Review and evaluate customer service requests, monitor email box for requests, maintain high level of service, and follow through on all communications
Ensure communications convey all necessary detail and adhere to applicable regulatory standards
Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates, and IT
Support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
Participate in projects affecting GTS licenses and perform other related duties as assigned

Skills

Regulatory Operations

Global Trade Services

GTS Licenses

SOPs

Product Releases

Regulatory Compliance

Supply Chain

Quality Management Systems

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

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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