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 and identify/resolve problems
Expertise in providing regulatory guidance to cross-functional partners
Knowledge of complex worldwide regulatory strategies, with support from international regulatory affiliates
Ability to compile, prepare, review, and submit medical device submissions to regulatory agencies
Experience interfacing directly with FDA and other regulatory agencies
Skills in maintaining ongoing surveillance and analysis of domestic and international medical device regulations
Proficiency in ensuring submission requirements are current and updating databases/file systems
Ability to review device labeling for compliance with FDA submissions and regulations
Capability to support product release processes (e.g., creating GTS licenses, reviewing/approving requests)
Experience conducting reviews of product and manufacturing changes for regulatory compliance
Familiarity with supporting business segment initiatives, Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Compliance with U.S. FDA and international regulations, company policies, procedures, and processes
Strong communication and collaboration skills across all levels of employees, customers, contractors, and vendors
Ability to provide mentoring and leadership to other Regulatory team members

Responsibilities

Prepare robust regulatory applications to achieve departmental and organizational objectives
Act as regulatory representative on core product development teams, communicating regulatory requirements and impacts
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 clear and detailed communications
Maintain surveillance and analysis of domestic and international medical device regulations, updating databases and distributing new/modified information
Review device labeling for compliance with FDA submissions and applicable regulations
Support product release process by creating GTS licenses or reviewing/approving requests
Conduct reviews of product and manufacturing changes for compliance with commercial and clinical regulations
Support business segment initiatives as identified by divisional management, in alignment with QMS, EMS, and other requirements
Comply with FDA, international regulations, company policies, procedures, processes, and task assignments
Maintain positive communications and collaboration with employees, customers, contractors, and vendors

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory SubmissionsRegulatory ApprovalsMedical DevicesElectrophysiologyCross-functional CollaborationRegulatory Guidance

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.

Is this position remote or on-site?

This is an on-site position in Plymouth, MN.

What are the key responsibilities for this role?

The role involves preparing and submitting regulatory applications, acting as a regulatory representative on product development teams, providing guidance on worldwide strategies, interfacing with FDA and other agencies, and maintaining surveillance of medical device regulations.

What is Abbott's company culture like?

Abbott emphasizes doing work that matters, personal growth and learning, caring for yourself and family, being your true self, career development in an international company, and is recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this Senior Regulatory Affairs Specialist role?

A strong candidate is passionate and experienced in regulatory affairs, capable of leading preparation and submission of regulatory approvals, providing guidance to cross-functional teams, interfacing with FDA and international agencies, and staying current on worldwide medical device regulations.

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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