Regulatory Affairs Expert for Global Diabetes Care
5 days ago
Are you a highly skilled Regulatory Affairs Specialist looking to take your career to the next level in the dynamic field of Diabetes Care? Join Abbott Laboratories, a global leader in healthcare, as a Regulatory Affairs Specialist III.
About UsWe are a pioneering company that helps people live more fully at all stages of life. Our diverse portfolio of innovative technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. With over 114,000 colleagues serving people in more than 160 countries, we strive to make a meaningful impact on society.
Job SummaryThis exciting opportunity is based in our Austin, TX location within the Abbott Diabetes Care Division. As a Regulatory Affairs Specialist III, you will play a vital role in supporting change control for manufacturing/operations activities and providing regulatory direction on cross-functional projects. You will work closely with teams to prepare U.S. regulatory submissions and registration documents for the US FDA and international affiliates.
Responsibilities:- Execute regulatory deliverables related to product development, submissions, product maintenance, and project plans
- Implement Division Regulatory Strategy to support product and process change projects
- Leverage knowledge of laws and regulations to ensure compliance
- Analyze input from cumulative product changes and draft letter to file documentation to support regulatory assessment
- Collaborate with teams to share knowledge and implement quality management systems
To be successful in this role, you should possess a Bachelor's Degree or an equivalent combination of education and experience, with 5 years of work experience. A background in technical disciplines such as biology, chemistry, microbiology, immunology, or medical technology is preferred. Previous experience in Medical Devices and regulatory affairs is also advantageous.
BenefitsAs a valued member of our team, you can expect a competitive salary ranging from $64,000 to $128,000, depending on specific locations. In addition, you will enjoy access to our excellent retirement savings plan, tuition reimbursement, and health investment plan (HIP) PPO medical plan. Our company culture values diversity and inclusion, offering opportunities for growth and development. We are committed to creating a workplace where everyone feels valued and empowered to succeed.
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Austin, Texas, United States Abbott Laboratories Full timeAbout Abbott LaboratoriesAbbott Laboratories is a leading global healthcare company that helps people live more fully at all stages of life. Our diverse portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.Job OverviewThis...
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Austin, Texas, United States Abbott Laboratories Full timeUnlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Specialist III to join our team at Abbott Laboratories. As a key member of our Diabetes Care Division, you will play a critical role in ensuring the quality and regulatory compliance of our products.About the Role:This is an exciting opportunity to work on-site in...
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Austin, Texas, United States Abbott Laboratories Full timeAt Abbott Laboratories, we're committed to improving the quality of life for people around the world. As a Regulatory Affairs Specialist III in our Diabetes Care Division, you'll play a crucial role in ensuring our products meet regulatory requirements and are brought to market efficiently.As part of our team, you'll be responsible for executing regulatory...
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