Senior Regulatory Affairs Specialist - Electrophysiology (on-site) at Abbott

Plymouth, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Passionate and experienced in regulatory affairs
Ability to lead preparation and submission of regulatory approvals
Expertise in identifying and resolving regulatory problems
Knowledge to provide regulatory guidance to cross-functional partners
Experience acting as regulatory representative on core product development teams
Ability to communicate regulatory requirements and impacts
Expertise on complex worldwide regulatory strategies, with help from international affiliates
Skills to compile, prepare, review, and submit medical device submissions to regulatory agencies
Experience interfacing directly with FDA and other regulatory agencies
Ability to act as liaison between company and regulatory agencies
Capability to maintain ongoing surveillance and analysis of domestic and international medical device regulations
Proficiency in ensuring submission requirements are current and distributed appropriately
Skills to review device labeling for compliance with FDA and regulations
Experience supporting product release processes (e.g., creating GTS licenses, reviewing approvals)
Ability to conduct reviews of product and manufacturing changes for regulatory compliance
Capacity to support business segment initiatives, QMS, EMS, and other requirements
Compliance with FDA, international regulations, company policies, and procedures
Strong communication and collaboration skills across all levels
Ability to provide mentoring and leadership to regulatory team members

Responsibilities

Prepare robust regulatory applications to achieve departmental and organizational objectives
Act as regulatory representative on core product development teams and communicate regulatory requirements
Provide guidance and expertise on complex worldwide strategies with international regulatory affiliates
Compile, prepare, review, and submit medical device submissions to regulatory agencies
Interface directly with FDA and other regulatory agencies
Act as liaison between the company and regulatory agencies, ensuring effective communications
Maintain surveillance and analysis of domestic and international regulations, updating databases and distributing information
Review device labeling for compliance with FDA submissions and regulations
Support product release process by creating GTS licenses or reviewing/approving requests
Conduct reviews of product and manufacturing changes for compliance with regulations
Support business segment initiatives, QMS, EMS, and other regulatory requirements
Comply with FDA, international regulations, company policies, procedures, and assignments
Maintain positive communications and collaboration with employees, customers, contractors, and vendors
Provide mentoring and leadership to other regulatory team members

Skills

Regulatory Affairs

Regulatory Submissions

Regulatory Approvals

Electrophysiology

Medical Devices

Atrial Fibrillation

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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