Abbott
Principal Regulatory Affairs Specialist – US New Product Introduction – Diabetes
Abbott, Alameda, California, United States, 94501
Overview
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. 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. Abbott believes people with diabetes should have the freedom to enjoy active lives. We focus on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We are revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors have revolutionized how roughly 6 million people worldwide manage their diabetes. The Opportunity
The Principal RA Specialist – US New Product Introduction will work on-site in Alameda, CA within the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors have transformed diabetes management for millions worldwide. This role involves responsibility for US submissions for new product introductions, including breakthroughs in diabetes management and digital health technology solutions to address customer needs. Projects will focus on premarket submissions for our portfolio of continuous glucose monitoring systems. Working knowledge of insulin and drug solutions for diabetes management or past experience in submitting NDA/BLA submissions is preferred. The individual will have department-level influence with experience in US submissions and on-market changes, and is generally recognized as an expert resource both within Abbott and externally. The role may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategies, and provide executive management with regulatory metrics/information. What You’ll Work On
Develop global regulatory strategies for product development and planning throughout the product lifecycle. Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. Provide technical leadership and strategic input on complex issues to business units. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with regulatory and related teams. Create project plans and timelines. Lead functional groups in the development of relevant data to complete a regulatory submission. Write and edit technical documents. Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions. Negotiate with regulatory authorities during the development and review process to ensure submission approval. Review and approve labeling to ensure compliance. Monitor emerging issues and identify solutions. Negotiate internally and externally with regulatory agencies. Evaluate regulatory risks of corporate policies. Oversee processes involved with maintaining annual licenses, registrations, listings and patent information. Ensure compliance with product post-marketing approval requirements. Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events. Actively contribute to the development and functioning of the crisis/issue management program. Analyze product-associated problems and develop proposals for solutions. Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall communications. Required Qualifications
Bachelor’s Degree in a scientific discipline (e.g., Chemistry, Life Sciences, Biology) or equivalent vocational qualifications. Experience in regulatory submissions for pharmaceuticals, medical devices, and/or in vitro diagnostic devices. Experience with 21 CFR 820, ISO 13485, Medical Devices Directive (93/42/EEC) and/or IVD Directive (98/79/EC) requirements. Preferred Qualifications
5 years’ experience with Class II/III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. Experience with 510(k) applications, PMA supplements, NDA, BLA, US device regulations, and international device regulations. Familiar with quality systems, clinical investigations, ICH guidelines. Experience with word processing, spreadsheets and presentation software. Experience in a broader enterprise/cross-division model and in a highly matrixed, geographically diverse environment. Ability to work as part of a team and as an individual contributor in a fast-paced environment. Strong verbal and written communication skills at multiple levels of the organization. Ability to multitask, prioritize and meet deadlines; strong organizational and detail-oriented skills. Ability to travel approximately 5%, including international travel. Apply now. Abbott is an Equal Opportunity Employer committed to employee diversity. Learn more about our health and wellness benefits at Abbott Benefits. Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. For accommodations, contact corpjat@abbott.com.
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. 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. Abbott believes people with diabetes should have the freedom to enjoy active lives. We focus on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We are revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors have revolutionized how roughly 6 million people worldwide manage their diabetes. The Opportunity
The Principal RA Specialist – US New Product Introduction will work on-site in Alameda, CA within the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors have transformed diabetes management for millions worldwide. This role involves responsibility for US submissions for new product introductions, including breakthroughs in diabetes management and digital health technology solutions to address customer needs. Projects will focus on premarket submissions for our portfolio of continuous glucose monitoring systems. Working knowledge of insulin and drug solutions for diabetes management or past experience in submitting NDA/BLA submissions is preferred. The individual will have department-level influence with experience in US submissions and on-market changes, and is generally recognized as an expert resource both within Abbott and externally. The role may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategies, and provide executive management with regulatory metrics/information. What You’ll Work On
Develop global regulatory strategies for product development and planning throughout the product lifecycle. Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. Provide technical leadership and strategic input on complex issues to business units. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with regulatory and related teams. Create project plans and timelines. Lead functional groups in the development of relevant data to complete a regulatory submission. Write and edit technical documents. Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions. Negotiate with regulatory authorities during the development and review process to ensure submission approval. Review and approve labeling to ensure compliance. Monitor emerging issues and identify solutions. Negotiate internally and externally with regulatory agencies. Evaluate regulatory risks of corporate policies. Oversee processes involved with maintaining annual licenses, registrations, listings and patent information. Ensure compliance with product post-marketing approval requirements. Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events. Actively contribute to the development and functioning of the crisis/issue management program. Analyze product-associated problems and develop proposals for solutions. Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall communications. Required Qualifications
Bachelor’s Degree in a scientific discipline (e.g., Chemistry, Life Sciences, Biology) or equivalent vocational qualifications. Experience in regulatory submissions for pharmaceuticals, medical devices, and/or in vitro diagnostic devices. Experience with 21 CFR 820, ISO 13485, Medical Devices Directive (93/42/EEC) and/or IVD Directive (98/79/EC) requirements. Preferred Qualifications
5 years’ experience with Class II/III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. Experience with 510(k) applications, PMA supplements, NDA, BLA, US device regulations, and international device regulations. Familiar with quality systems, clinical investigations, ICH guidelines. Experience with word processing, spreadsheets and presentation software. Experience in a broader enterprise/cross-division model and in a highly matrixed, geographically diverse environment. Ability to work as part of a team and as an individual contributor in a fast-paced environment. Strong verbal and written communication skills at multiple levels of the organization. Ability to multitask, prioritize and meet deadlines; strong organizational and detail-oriented skills. Ability to travel approximately 5%, including international travel. Apply now. Abbott is an Equal Opportunity Employer committed to employee diversity. Learn more about our health and wellness benefits at Abbott Benefits. Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. For accommodations, contact corpjat@abbott.com.
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