Regulatory Affairs Manager – Heart Failure (On-Site)
Location: Pleasanton, California, United States
Employment Type: Full-Time, On-Site
Category: Regulatory Affairs
Experience Required: Minimum 6 years in regulatory affairs, medical device or healthcare products
About Abbott
Abbott is a global healthcare leader committed to improving lives at every stage. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generics, serving millions of patients worldwide. With over 114,000 colleagues in more than 160 countries, Abbott combines scientific innovation with regulatory excellence to bring life-changing healthcare solutions to market.
The Heart Failure Division develops technologies and therapies to monitor, manage, and improve cardiac health, enabling patients to restore their quality of life and achieve better outcomes.
Role Overview
Abbott is seeking a Regulatory Affairs Manager to join our Heart Failure Division on-site in Pleasanton, CA. As an individual contributor, this role combines scientific, regulatory, and business expertise to ensure products comply with domestic and international regulations and are successfully registered and released for market. This role provides department-level guidance and is recognized as an expert resource for regulatory strategy, submission management, and cross-functional collaboration.
Key Responsibilities
Regulatory Expertise
Develop and implement regulatory strategies for medical devices, including 510(k), IDE, PMA, PMA supplements, and international submissions.
Anticipate regulatory challenges and emerging issues across multiple geographies.
Interpret and apply regulatory requirements including product laws, advertising, labeling, and clinical requirements.
Maintain awareness of domestic and international regulations, policies, and ethical guidelines.
Communication & Collaboration
Communicate complex regulatory plans clearly to senior leaders and cross-functional teams.
Prepare, review, and edit technical documents, submissions, and regulatory correspondence.
Negotiate with internal and external stakeholders, including regulatory agencies.
Facilitate cross-functional meetings and project coordination.
Analytical & Cognitive Skills
Perform risk assessments and regulatory impact analyses.
Organize and manage complex regulatory information and multiple concurrent projects.
Exercise independent judgment in selecting strategies, methodologies, and solutions.
Lead functional groups to generate necessary data for regulatory submissions.
Leadership & Influence
Provide guidance to cross-functional teams on regulatory strategy and compliance.
Lead projects and initiatives with enterprise-level impact.
Influence and align stakeholders across the division to achieve regulatory objectives.
Required Qualifications
Bachelor’s degree in a technical discipline (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology, engineering, or equivalent).
Minimum 6 years of regulatory experience, preferably with medical devices or healthcare products.
Experience with US, EU (MDR), and international medical device regulations and submissions.
Strong written and verbal communication skills, with the ability to interact at multiple organizational levels.
Ability to manage complex projects independently in a fast-paced, matrixed environment.
Preferred Qualifications
Advanced degree in a scientific, technical, or regulatory field.
8+ years of regulatory experience, including supervisory or managerial responsibilities.
Experience with medical device software regulations and risk management.
Proven ability to identify regulatory risks and escalate issues appropriately.
RAC certification or equivalent professional regulatory certification is a plus.
Benefits & Career Growth
At Abbott, employees enjoy:
Career development and training programs with tuition assistance.
Comprehensive healthcare benefits, including medical, dental, vision, and wellness programs.
Retirement plans with generous company match.
Paid time off and flexible work arrangements.
Opportunity to work on innovative heart failure technologies impacting patient care worldwide.
Learn more: www.abbottbenefits.com
Why Join Abbott
Abbott offers regulatory professionals a platform to influence global product launches, lead cross-functional teams, and contribute to life-changing healthcare solutions. Abbott is an Equal Opportunity Employer, committed to diversity, equity, and inclusion.
Base Salary: $112,000 – $224,000 (location-dependent)
Apply Now to advance your regulatory affairs career with Abbott.
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