Principal Regulatory Affairs Specialist (Business Partnerships)
Location: Alameda, California, United States
Category: Regulatory Affairs
About Abbott
Abbott is a global healthcare leader dedicated to advancing diagnostics, medical devices, nutrition, and branded generic medicines. With more than 114,000 employees across 160 countries, Abbott focuses on improving health outcomes and helping people live fuller, healthier lives.
Working at Abbott
Abbott offers an environment where professionals can contribute meaningful work, develop their careers, and thrive personally and professionally. Employees benefit from:
International career development and long-term growth opportunities
Eligibility for free medical coverage through the Health Investment Plan (HIP) PPO
Competitive retirement savings plans with high employer contributions
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU degree pathways
Global recognition as a top employer for diversity, leadership, and workplace culture
Abbott’s Diabetes Care division is committed to empowering people with diabetes through advanced glucose monitoring solutions. Technologies such as the FreeStyle Libre system have transformed the daily management of diabetes for millions globally.
Position Overview
The Principal Regulatory Affairs Specialist (Business Partnerships) will be based on-site in Alameda, California, supporting strategic global initiatives within Abbott’s Diabetes Care Division. This role focuses on driving regulatory strategies related to business partnerships involving cloud-based platforms, sensor technology, and digital health solutions.
The position requires deep regulatory expertise, strong cross-functional influence, and the ability to develop innovative regulatory pathways for new business models and technology integrations.
Key Responsibilities
Regulatory Strategy and Leadership
Develop global regulatory strategies to support product development and lifecycle management.
Analyze regulatory outcomes and align them with product concepts and long-term business goals.
Provide expert-level guidance to business units on complex regulatory issues.
Identify emerging regulatory challenges and propose proactive solutions.
Submission Development and Compliance
Support teams in generating required data for regulatory submissions.
Write, review, and edit technical and scientific documents.
Ensure compliance with all regulatory standards, maintaining a strong compliance posture with no enforcement actions.
Review and approve product labeling for global regulatory compliance.
Manage regulatory requirements related to post-marketing activities.
Business Partnerships and Collaboration
Lead regulatory planning for external partnerships involving cloud and sensor-based technologies.
Oversee processes and improvements related to partnership regulatory activities.
Serve as a key liaison internally and externally, including negotiations with regulatory authorities and participation in trade associations.
Provide regulatory assessments of corporate policies and business initiatives.
Operations, Risk, and Issue Management
Develop and maintain SOPs and systems for tracking product-related events.
Contribute to crisis and issue management programs.
Analyze product issues and propose corrective strategies.
Provide regulatory guidance for product recalls and communications.
Required Qualifications
Bachelor’s degree in a scientific discipline (Chemistry, Life Sciences, Biology, or equivalent).
Proven experience in regulatory submissions for pharmaceuticals, in vitro diagnostics, and/or medical devices.
Working knowledge of regulatory frameworks including:
21 CFR 820
ISO 13485
Medical Devices Directive (93/42/EEC)
IVD Directive (98/79/EC)
Preferred Qualifications
Minimum 5 years of experience with Class II or Class III medical devices and/or biologics/drugs.
Experience with 510(k) submissions, PMA supplements, U.S. FDA regulations, EU MDR/IVDR, and other global regulatory pathways.
Familiarity with Quality Systems, clinical investigation standards, and ICH guidelines.
Experience working in cross-division or enterprise-level structures.
Strong ability to work independently and collaboratively in a fast-paced, matrixed environment.
Demonstrated ability to lead projects, influence stakeholders, and solve complex regulatory problems.
Excellent written and verbal communication skills.
Strong organizational and time-management capabilities.
Ability to travel approximately 5% domestically or internationally.
Apply Now
Learn more about Abbott’s comprehensive health and wellness benefits at abbottbenefits.com.
Abbott is an Equal Opportunity Employer committed to fostering diversity and inclusion across its global workforce.
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