Senior Manager, Regulatory Affairs - Lingo (on-site)

Job Title Senior Regulatory Affairs Manager Location Alameda, CA, United States Salary $130,700.00 – $261,300.00 (base) Key Responsibilities Lead regulatory affairs activities for product registration worldwide, including compiling regulatory submissions and ensuring data is effectively presented. Develop and execute regulatory strategies, approval schedules, and submission standards to meet organizational objectives. Review labeling, advertising, and promotional materials with marketing teams to provide regulatory strategy and compliance input. Assist with content development and review for promotional materials to ensure regulatory compliance before distribution. Develop and oversee Regulatory Affairs Advertising & Promo Standard Operating Procedures. Recruit, coach, and develop regulatory talent, including supervising exempt specialists and providing direction to achieve departmental goals. Monitor compliance with company policies and external regulations such as FDA, BSI, and EEO. Make decisions regarding work processes and operational plans to achieve departmental objectives. Develop, monitor, and adjust the annual budget for the regulatory department. Lead change initiatives and build strategic partnerships to support organizational goals. Required Qualifications Bachelor’s Degree in a related field or equivalent combination of education and experience. Minimum 9 years of related work experience. Experience providing direction and monitoring progress of exempt specialists and/or supervisory staff toward departmental goals. Ability to monitor costs of projects and resources within a department or unit. Experience monitoring company-wide indicators such as market share and profitability. Proficiency in developing and communicating a vision for assigned organizational units. Experience in developing and identifying new work processes to improve utilization of human and material resources. Strong analytical thinking and problem‑solving skills. Preferred Qualifications Master’s degree. Experience with submission/registration types and requirements for Class III implantable devices. Experience managing and leading a team. Knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (MDR), and other international geographies. Experience with medical device software requirements and software regulations. Ability to identify risk areas and appropriately escalation issues. Certification is a plus (e.g., RAC from the Regulatory Affairs Professionals Society). Benefits and Additional Information Travel: Yes, up to 10 % of the time. Medical surveillance: No. Significant work activities: Awkward/forceful/repetitive motion, continuous sitting for prolonged periods. Equal Opportunity Employer Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law. English: Spanish: #J-18808-Ljbffr Abbott Laboratories