Principal Regulatory Affairs Specialist (Business Partnerships) – On-site (Alameda, CA)
Job Summary
Abbott’s Diabetes Care Division is seeking a Principal Regulatory Affairs Specialist (Business Partnerships) to join their innovative team in Alameda, California. This senior-level role offers the unique opportunity to drive global regulatory strategies for next-generation digital health and diabetes management products, including cloud and sensor-based technologies. Ideal for regulatory experts looking to influence worldwide health technology partnerships.
Key Responsibilities
Develop and execute global regulatory strategies throughout the product lifecycle.
Provide technical leadership on complex regulatory issues to cross-functional teams.
Anticipate regulatory challenges and create solutions across product lifecycles.
Plan and manage regulatory submission timelines and content.
Prepare and edit technical documents supporting global submissions.
Ensure regulatory compliance and uphold post-marketing approval requirements.
Approve product labeling to maintain regulatory adherence.
Evaluate and manage regulatory risks tied to corporate policies.
Drive processes and improvements related to partnership regulatory activities.
Oversee SOP development and event tracking systems.
Contribute to crisis and issue management programs.
Support regulatory strategy for product recalls and communications.
Maintain strong regulatory agency and trade association relationships.
Required Skills & Qualifications
Bachelor’s Degree in a Scientific field (e.g., Chemistry, Biology, Life Sciences).
Demonstrated expertise in regulatory submissions for medical devices, IVDs, or pharmaceuticals.
Knowledge of 21 CFR 820, ISO 13485, Medical Devices Directive (93/42/EEC), IVD Directive (98/79/EC).
5+ years working with Class II/III medical devices or biologics/drugs.
Experience with 510(k), PMA submissions, and global medical device regulations.
Proficiency in MS Office, spreadsheets, and presentation software.
Strong problem-solving and cross-functional leadership skills.
Ability to work independently and within matrixed teams.
Strong written and verbal communication at all organizational levels.
Ability to travel up to 5%, including internationally.
Perks & Benefits
Salary Range: $98,000 – $196,000 annually.
Free medical coverage under HIP PPO plan (eligibility dependent).
Excellent 401(k) retirement savings with high employer contribution.
Tuition reimbursement & Freedom 2 Save student debt program.
FreeU education benefit for affordable bachelor’s degree.
Career advancement in a globally recognized healthcare leader.
Company Description
Abbott is a world-renowned healthcare innovator delivering transformative solutions in diagnostics, medical devices, nutrition, and pharmaceuticals. Serving customers in over 160 countries, Abbott empowers healthier living through cutting-edge science and technology.
Work Mode
On-site – Alameda, California, United States
Call to Action
Take your regulatory career to new heights! Apply now to shape the future of digital health technology with Abbott and contribute to global healthcare innovation.
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