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Abbott is a global healthcare leader offering technologies in diagnostics, medical devices, nutritionals, and branded generic medicines. The Manager Regulatory Affairs position is located in Sylmar, CA, within the Cardiac Rhythm Management Business. Reporting to the Director of Regulatory Affairs, this role manages and leads Regulatory Affairs activities for implantable cardiac pacemaker and defibrillator devices and accessories. Responsibilities include leading global regulatory strategies, submissions for clinical trials and product launches, managing resources, and ensuring compliance with US FDA, EU MDR, and other international regulations. The role involves managing a team, employee development, strategic oversight, and cross-functional collaboration. Key duties include recruiting and coaching talent, developing regulatory strategies, guiding Regulatory Affairs specialists, monitoring compliance, managing budgets, preparing and submitting regulatory documents (IDEs, PMAs, 510(k)s, EU MDR Technical Files), interfacing with regulatory agencies, and supporting post-market activities. Required qualifications include a Bachelor's degree in relevant fields, 8-10 years of experience with at least 5 years in regulated industry, and knowledge of US and international medical device regulations. Preferred qualifications include Regulatory Affairs Certification, experience with combination products, and supervisory experience. The role requires strong leadership, communication, organizational, and problem-solving skills, and the ability to work independently and in a matrixed environment.