Regulatory Affairs Manager - Medical Device

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.ABOUT ABBOTT DIAGNOSTICS:The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott''s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.Our pioneering technology spans the world of healthcare operations "” with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.Our location in Irving, TX, currently has an opportunity for Regulatory Affairs Project Manager, Medical Devices.WHAT YOU''LL DOThe Project Manager, Regulatory Affairs within Abbott Diagnostics leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.Responsibilities:Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Responsible for implementing and maintaining the effectiveness of the quality system.Develops sound global regulatory strategies for new and modified medical devices.Prepares robust regulatory applications to achieve departmental and organizational objectives.Creates, reviews and approves engineering changes.Provides leadership and guidance (including training) to other members of the RA staff.Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.Provides Regulatory leadership to development teams:Provides global strategic input (including all feasible alternatives and associated risks).Drives cross functional alignment with issues that could have Regulatory dependently interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies).Builds strategic partnerships to further departmental and organizational objectives.Reviews of product and manufacturing changes for compliance with applicable regulations (Change Control).Reviews protocols and reports to support regulatory submissions.Assesses proposed regulations and communicates new requirements to the organization.Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory plies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Assists with audits and inspections, if required.EDUCATION AND EXPERIENCE YOU''LL BRINGRequiredBachelor''s degree (or equivalent), Bachelor''s degree in Science, Math Engineering, or Medical fields is preferred.M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.4-5 years experience in a regulated industry (e.g., medical products, nutritionals).PreferredBachelor''s degree in a technical discipline highly preferred6 + years Regulatory experience; 8 years preferredExperience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.Experience working in a broader enterprise/cross-division business unit model preferred.Multitasks, prioritizes and meets deadlines in timely manner.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Strong organizational and follow-up skills, as well as attention to detail.Additional Job DescriptionAbility 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.Ability to travel approximately 5%, including internationally. Ability to maintain regular and predictable attendance.Ability to work independently with no oversight.Ability to identify and solve problems in a strategic manner.Ability to manage complex projects.Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully:"¯ Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at on LinkedIn at on Facebook at and on Twitter @AbbottNews."‹

Created: 2021-11-29