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Lead Specialist in Regulatory Affairs Operations
2 months ago
Abbott is a prominent player in the global healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of 114,000 professionals, we serve communities in over 160 countries worldwide.
Position Overview:
As a Lead Specialist in Regulatory Affairs Operations, you will be an integral part of our team in the Diabetes Care Division, based in Alameda, CA. Our mission is to empower individuals with diabetes to effectively manage their health through innovative products that deliver precise data for informed decision-making.
Your Role:
In this individual contributor position, you will support the regulatory department to facilitate efficient and compliant business operations. Your responsibilities will include:
- Collaborating across various business functions to execute tasks and provide consultative support.
- Identifying necessary data, obtaining it, and ensuring effective presentation for the global registration of digital products.
- Preparing and overseeing the submission of documentation required for worldwide registration.
- Contributing to the development of regulatory strategies and adapting them in response to regulatory changes.
- Engaging in risk-benefit analyses to ensure regulatory compliance.
- Monitoring the impact of evolving regulations on submission strategies and applications under review.
Qualifications:
To be successful in this role, you should possess:
- A Bachelor's degree or equivalent experience.
- 2-3 years of experience in regulatory affairs or related fields.
- 3-4 years of experience in a regulated industry, such as medical products or nutritionals.
Preferred Skills:
We value candidates with:
- A degree in a scientific or engineering discipline.
- Strong analytical and organizational skills.
- Excellent written and verbal communication abilities.
At Abbott, we are committed to fostering a diverse and inclusive workplace. Join us in our mission to make a meaningful impact in the healthcare industry.
