Senior Regulatory Specialist

JOB DESCRIPTION

Senior Regulatory Affairs Specialist Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists Our mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment. The Opportunity This Senior Regulatory Affairs Specialist will work out of our Pleasanton, CA location in the Heart Failure Division. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department. With limited supervision you will execute tasks and partner across business functions. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities. What You’ll Work On Direct development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interact with FDA and other regulatory agencies to expedite approval of pending registrations. Serve as regulatory liaison throughout product lifecycle. Participate in product plan development and implementation, regulatory strategy, risk management. Ensure timely approval of medical devices and continued approval of marketed products. Interface directly with FDA and other regulatory agencies. Support the product release process by creating GTS licenses or reviewing and approving requests for product release. Conduct reviews of product and manufacturing changes for compliance with applicable regulations. Create, review and approve engineering change orders. Review protocols and reports to support regulatory submissions. Support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Serve as regulatory representative to marketing, research teams and regulatory agencies. Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Required Qualifications Bachelor’s Degree (± 16 years) in a technical discipline highly preferred or an equivalent combination of education and work experience. Minimum 5 years of technical experience, including at least 4 years of regulatory experience in a medical device industry. Experience with 510(k) applications, PMA supplements and US device regulations and/or EU and other international medical device regulations and submissions. Experience working in a broader enterprise/cross-division business unit model preferred. 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 and/or engage others to accomplish projects. Strong verbal and written communication with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in an intimate manner. Strong organization and follow‑up skills, as well as attention to detail. Ability to travel approximately 5%, including internationally. Preferred Qualifications Master’s Degree (± 18 years) in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience. Minimum 3 years, 3‑4 years experience in a regulated industry (e.g., medical products, nutritionals). 2‑3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). Experience with review of labeling, promotional, and or advertising materials is highly desired. Familiar with principles and requirements of promotion, advertising and labeling. Office program skills to include Word, Excel, PowerPoint, Adobe Acrobat and SharePoint. Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields. Master’s Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience. Base Pay $90,000.00 – $180,000.00 In specific locations, the pay range may vary from the range posted. Equal Opportunity Employer Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Español: #J-18808-Ljbffr Abbott