Senior Regulatory Affairs Specialist - Vascular (on-site)

Senior Regulatory Affairs Specialist – Santa Clara, CA This onsite position is located in the Abbott Vascular Division and focuses on supporting regulatory processes to ensure efficient and compliant business operations. The role provides regulatory input across the product lifecycle and partners with cross‑functional teams. Responsibilities Strategic Planning Provide regulatory input to product lifecycle planning. Assist in the development of regional regulatory strategy and update strategy based on regulatory changes. Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assess regulatory implications for approval. Determine and communicate submission and approval requirements. Participate in risk‑benefit analysis for regulatory compliance. Premarket Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities. Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. Postmarket Maintain annual licenses, registrations, and listings. Assist in compliance with product post‑marketing approval requirements. Assess external communications relative to regulations. Assist with labeling development and review for compliance before release. Support change management process to assess regulatory impact of change and consequent submission requirements. Analyze the impact of cumulative product changes to current product submissions. Participate in compliance activities by providing regulatory input for non‑conforming products, field actions, and CAPA. Assist in site audits conducted by internal and external auditing bodies. Benefits Career development with an international company. Employees qualify for free medical coverage under the Health Investment Plan (HIP) PPO medical plan. Excellent retirement savings plan with high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for bachelor’s degrees. Recognized by Fortune as one of the most admired companies and a great place to work in numerous countries. Commitment to diversity, working mothers, female executives, and scientists. Required Qualifications Bachelor's Degree in a related field or an equivalent combination of education and work experience. 3–4 years of experience in a regulated industry (e.g., medical products, nutritionals). Higher education may compensate for years of experience. 2–3 years of regulatory experience preferred, but experience in quality assurance, R&D/support, scientific affairs, operations, or related areas may be considered. Effective verbal and written communication skills, including preparation and negotiation with regulatory agencies. Strong organizational and follow‑up skills, with attention to detail. Ability to organize and track complex information. Exercise good and ethical judgment within policy and regulations. In-depth knowledge of business functions and cross‑group dependencies/relationships. Follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues with supervision. Preferred Qualifications Bachelor's degree in science/technical disciplines such as engineering or life sciences. China regulatory affairs experience. Experience with U.S. (510(k), PMA) and EU (Technical Documentation, Change Notification) submissions. Experience interacting with U.S. FDA and EU Notified Bodies. Experience in highly regulated international markets (e.g., China, Canada, Australia, Brazil). Experience reviewing clinical data. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast‑paced, changing environment. Ability to leverage, manage and/or engage others to accomplish projects. Applies critical thinking to multitask, prioritize and meet deadlines in a timely manner. Experience working in the medical device industry. Certification is a plus (e.g., RAC from the Regulatory Affairs Professionals Society). Master’s degree. Abbott is an Equal Opportunity Employer, committed to employee diversity. Base pay: $90,000.00 – $180,000.00 (range may vary by location). #J-18808-Ljbffr Abbott