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, especially FDA and worldwide regulatory agencies
Ability to perform specialized level work assignments and analyses, evaluation, preparation, and submission of documentation for regulatory registration
Compliance with U.S. Food and Drug Administration (FDA) regulations, international regulations, company policies, operating procedures, processes, and task assignments
Positive and cooperative communication and collaboration skills with all levels of employees, customers, contractors, and vendors

Responsibilities

Preparation of 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 both new product development projects and sustaining activities
Act as a regulatory representative responsible for review and analysis of applicable regulatory guidelines
Review and evaluate communications to ensure they convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates
Maintain pertinent domestic and international medical device regulations to ensure submission requirements worldwide are current, up-to-date, and entered into regulatory submission database and file systems
Distribute information on new or modified regulations and requirements to appropriate personnel, if requested
Support the product release process by collaborating with the Regulatory Operations team and ensuring products are released in a compliant and timely manner
Interface directly with FDA and other regulatory agencies if directed
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Perform other related duties and responsibilities as assigned

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory SubmissionsMedical DevicesElectrophysiologyRegulatory ComplianceDocumentation PreparationRegulatory Evaluation

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides career development opportunities, free medical coverage through the Health Investment Plan (HIP) PPO, 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 main responsibilities of this role?

The role involves preparation of regulatory submissions for Electrophysiology devices, review and approval of engineering change orders, acting as a regulatory representative for guideline review, evaluating communications for regulatory standards, and maintaining domestic and international regulations.

What is the company culture like at Abbott?

Abbott emphasizes doing work that matters, growth and learning opportunities, caring for yourself and family, being your true self, and living a full life. It 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 experience makes a strong candidate for this role?

Abbott seeks a passionate, experienced Regulatory Affairs Specialist II with expertise in preparing regulatory submissions, reviewing engineering changes, analyzing regulatory guidelines, and maintaining compliance with FDA and international standards for Electrophysiology 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

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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