Senior Regulatory Product Specialist
5 hours ago
This Senior International Regulatory Product Specialist will play a key role in the Diabetes Care Division at Abbott, working on-site at our Alameda, CA location. Our team is dedicated to helping people with diabetes manage their health with innovative products that provide accurate data for informed decisions. We're revolutionizing glucose level monitoring with our new sensing technology.
Key Responsibilities- Support the regulatory department in ensuring efficient and compliant business processes and environment.
- Provide regulatory input to product lifecycle planning, identifying emerging regulations and interpreting them for stakeholders.
- Assist in SOP development and review, and participate in risk benefit analysis for regulatory compliance.
- Monitor impact of changing regulations on submission strategies and maintain annual licenses, registrations, listings, and patent information.
- Assist with label development and review for compliance, and contribute to the development and functioning of the crisis/issue management program.
- Provide regulatory input for product recalls and recall communications.
- Bachelor's degree in a relevant field.
- 3-4 years' experience in a regulated industry, with a strong understanding of regulatory history, guidelines, policies, standards, practices, requirements, and precedents.
- Regulatory agency structure, processes, and key personnel, as well as principles and requirements of applicable product laws.
- Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs), international treaties, and regional, national, local, and territorial trade requirements, agreements, and considerations.
- Domestic and international regulatory guidelines, policies, and regulations, as well as ethical guidelines of the regulatory profession, clinical research, and regulatory process.
- Bachelor's degree in science, math, engineering, or medical fields.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- 2-3 years of experience in regulatory, quality assurance, research and development/support, engineering, scientific affairs, operations, or related areas.
- Advanced level degree, experience with EU and other international medical device/drugs/pharma regulations and submissions, and design controls in medical devices, IVDR, Pharma industries.
- Proficient with Excel and PowerPoint, and presenting information to leadership.
- Previous experience working in a highly matrixed and geographically diverse business environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
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Fremont, California, United States Abbott Full timeAbout the RoleWe are seeking a highly skilled Senior International Regulatory Product Specialist to join our Diabetes Care Division at Abbott. As a key member of our team, you will play a critical role in ensuring the efficient and compliant business processes and environment for our regulatory department.Key ResponsibilitiesAssist in the development and...
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Fremont, California, United States Abbott Full timeAbout the RoleWe are seeking a highly skilled Senior International Regulatory Product Specialist to join our Diabetes Care Division at Abbott. As a key member of our team, you will play a critical role in ensuring the efficient and compliant business processes and environment for our regulatory department.Key ResponsibilitiesAssist in the development and...
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