Regulatory Affairs Specialist II – Electrophysiology (on-site) 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 DevicesIndustries

Requirements

Passionate and experienced in regulatory affairs
Knowledge of domestic and international medical device regulations, including FDA and worldwide agencies
Ability to perform specialized analyses, evaluations, preparation, and submission of regulatory documentation
Familiarity with U.S. Food and Drug Administration (FDA) regulations, international regulations, company policies, operating procedures, processes, and Quality Management Systems (QMS)
Strong communication and collaboration skills with employees, customers, contractors, vendors, and regulatory agencies
Capability to interface directly with FDA and other regulatory agencies if directed

Responsibilities

Prepare regulatory submissions for Electrophysiology devices to achieve departmental and organizational objectives
Review and approve engineering change orders for protocols, reports, specifications, and other project-related documentation supporting new product development and sustaining activities
Act as a regulatory representative to review and analyze applicable regulatory guidelines
Review and evaluate communications to ensure they convey necessary details and adhere to FDA and other worldwide regulatory standards for international affiliates
Maintain pertinent domestic and international medical device regulations, ensure submission requirements are current and entered into databases/file systems, and distribute new/modified information to appropriate personnel if requested
Support the product release process by collaborating with the Regulatory Operations team to ensure compliant and timely product releases
Interface directly with FDA and other regulatory agencies if directed
Support company initiatives for Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Comply with all FDA regulations, international regulations, company policies, operating procedures, processes, and task assignments
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Perform other related duties and responsibilities as assigned

Skills

Regulatory Affairs

Regulatory Submissions

Medical Devices

Electrophysiology

Compliance

Regulatory Registration

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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