Abbott – Principal Regulatory Affairs Specialist (US New Product Introduction)
Location: Alameda, CA (On-site)
Division: Diabetes Care
About Abbott
Abbott is a global healthcare leader helping people live more fully at every stage of life. With 114,000 colleagues serving people in more than 160 countries, we deliver life-changing technologies across:
Diagnostics
Medical Devices
Nutritionals
Branded Generic Medicines
Working at Abbott
At Abbott, you’ll do work that matters while growing your career and living your best life. We offer:
Career development opportunities with a global organization
Free medical coverage through our Health Investment Plan (HIP) PPO medical plan (eligible in the next calendar year)
Excellent retirement savings plan with high employer contribution
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit for bachelor’s degrees
Recognition as a Great Place to Work worldwide and named among Fortune’s Most Admired Companies
Inclusive culture recognized for diversity, working mothers, female executives, and scientists
Our Mission in Diabetes Care
We believe people with diabetes should have the freedom to live active lives. That’s why we’ve developed FreeStyle Libre continuous glucose monitors, used by nearly 6 million people globally. Our focus:
Accurate data for better-informed health decisions
Revolutionary sensing technology for improved glucose monitoring
Breakthrough solutions in digital health and diabetes management
The Opportunity
The Principal Regulatory Affairs Specialist will support US submissions for new product introductions in diabetes management. Responsibilities include:
Leading premarket submissions for continuous glucose monitoring (CGM) systems
Driving regulatory strategies for Class II/III medical devices, combination products, and digital health solutions
Providing regulatory leadership and expertise across Abbott and with external stakeholders
Monitoring and influencing regulatory guidance, interfacing with authorities and trade associations
Key Responsibilities
Regulatory Strategy & Leadership
Develop global regulatory strategies throughout the product lifecycle
Anticipate regulatory challenges and create solutions in collaboration with cross-functional teams
Provide strategic input and technical leadership on complex regulatory issues
Submissions & Compliance
Lead and prepare premarket submissions (510(k), PMA, NDA, BLA, etc.)
Ensure compliance with 21 CFR 820, ISO 13485, and international medical device regulations
Review and approve labeling to ensure compliance with US and international requirements
Stakeholder Engagement
Negotiate with regulatory authorities for submission approvals
Communicate regulatory requirements and metrics to executive leadership
Collaborate internally across divisions and externally with agencies
Post-Market & Safety
Oversee processes for annual licenses, registrations, listings, and patent information
Ensure compliance with post-marketing approval requirements
Provide regulatory input for product recalls and crisis management programs
Analyze product safety issues and oversee reporting to regulatory authorities
Required Qualifications
Bachelor’s Degree in a Scientific discipline (Chemistry, Life Sciences, Biology, or equivalent)
Experience in regulatory submissions for pharmaceuticals, medical devices, and/or IVDs
Knowledge of 21 CFR 820, ISO 13485, MDD (93/42/EEC), IVD Directive (98/79/EC)
Preferred Qualifications
5+ years of experience with Class II/III medical devices, biologics, or drugs
Regulatory Affairs Certification (RAC)
Experience with 510(k), PMA, NDA, BLA, and combination device/drug/biologic submissions
Familiarity with ICH guidelines, quality systems, and clinical investigations
Strong organizational, communication, and problem-solving skills
Ability to thrive in a matrixed, global business environment
Proficiency with MS Office (Word, Excel, PowerPoint)
Ability to travel ~5% (including internationally)
Compensation
Base Pay Range: $98,000 – $196,000
(Pay may vary by location)
How to Apply
Apply online and explore benefits at: www.abbottbenefits.com
Connect with us:
Website: www.abbott.com
Facebook: facebook.com/Abbott
Twitter: @AbbottNews | @AbbottGlobal
Abbott is an Equal Opportunity Employer committed to employee diversity.
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