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

Expertise in developing worldwide strategies for regulatory approval of new and modified products
Ability to prepare robust regulatory applications for FDA and/or international regulatory agencies
Experience 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, guiding content for submissions and participating in design reviews
Proficiency in maintaining annual licenses, registrations, and listing information, and assisting with post-marketing approval compliance
Subject Matter Expert (SME) status for audits and inspections by internal teams or external regulatory authorities
Skills in reviewing, editing, and approving Advertising and Promotional materials
Ability to act as liaison between the Company, in-country affiliates, and regulatory agencies
Competence in maintaining surveillance and analysis of medical device regulations worldwide, updating databases and distributing information
Support for product implementation processes, including creating database (GTS) licenses or reviewing/approving product release requests
Direct interfacing with regulatory agencies as needed
On-site availability in Pleasanton, CA

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 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 compliance to post-marketing approval requirements
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; partner across functions, identify/obtain data for worldwide product registrations; prepare/submit or oversee documentation for registrations

Skills

Regulatory Affairs

Compliance

Medical Devices

Healthcare Regulations

Business Processes

Regulatory Support

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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