Senior Regulatory Affairs Specialist – Heart Failure (on-site) at Abbott

Pleasanton, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Ability to work on-site in Pleasanton, CA
Expertise in developing worldwide strategies for regulatory approval of new and modified products
Experience preparing robust regulatory applications for FDA and/or international regulatory agencies
Knowledge of coordinating, compiling, and submitting regulatory submissions (e.g., European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, country-specific registrations)
Capability to represent Regulatory Affairs on cross-functional product development and manufacturing support teams
Proficiency in guiding teams for submission content and participating in design reviews
Skills in maintaining annual licenses, registrations, and listing information
Experience assisting with compliance to product post-marketing approval requirements
Subject Matter Expert (SME) level for audits and inspections by internal or external regulatory authorities
Ability to review, edit, and approve Advertising and Promotional materials
Competence in acting as liaison between the company, in-country affiliates, and regulatory agencies
Expertise in maintaining surveillance and analysis of medical device regulations worldwide, updating databases and distributing information
Knowledge of supporting product implementation processes (e.g., creating GTS database licenses, reviewing/approving product release requests)
Ability to interface directly with regulatory agencies

Responsibilities

Develop worldwide strategies for regulatory approval of new and modified products
Prepare robust regulatory applications for FDA and/or international regulatory agencies to achieve objectives
Coordinate, compile, and submit regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations
Represent Regulatory Affairs on cross-functional product development and manufacturing support teams; guide teams on submission content and participate in design reviews
Maintain annual licenses, registrations, and listing information; assist with post-marketing approval compliance
Serve as Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities
Review, edit, and approve Advertising and Promotional materials
Act as liaison between the Company, in-country affiliates, and regulatory agencies, ensuring relevant communications
Maintain ongoing surveillance and analysis of medical device regulations worldwide; update regulatory submission database and file systems; distribute new/modified regulation details
Support product implementation by creating database (GTS) licenses or reviewing/approving product release requests
Interface directly with regulatory agencies as needed
Provide support for the regulatory department to ensure efficient and compliant business processes
Execute tasks and play a consultative role by partnering across business functions
Assist in identifying data needed, obtaining it, and ensuring effective presentation for worldwide product registrations; prepare/submit or oversee such documentation

Skills

Regulatory Affairs

Regulatory Compliance

Medical Devices

Compliance Processes

Quality Systems

FDA Regulations

Risk Management

Documentation

Submissions

Labeling

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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