Principal Regulatory Affairs Specialist (Business Partnerships)
Location: United States – California – Alameda
Category: Regulatory Affairs
Company Overview
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Its portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines. With over 114,000 employees across 160+ countries, Abbott’s mission is to improve health through life-changing technologies.
Working at Abbott
At Abbott, you can:
Do meaningful work and grow professionally within an international organization.
Qualify for free medical coverage under the Health Investment Plan (HIP) PPO.
Enjoy an excellent retirement savings plan with high employer contributions.
Access tuition reimbursement, the Freedom 2 Save student debt program, and FreeU — a low-cost path to earning a bachelor’s degree.
Be part of one of the most admired companies worldwide (Fortune) and recognized as:
A best place to work for diversity, working mothers, female executives, and scientists.
Division Overview: Diabetes Care Division
Abbott believes people with diabetes deserve the freedom to live active, fulfilling lives. Its FreeStyle Libre Continuous Glucose Monitoring (CGM) systems have revolutionized diabetes management for nearly 6 million people worldwide.
This division focuses on digital health technologies and sensor-based innovations to enhance diabetes monitoring and patient outcomes.
The Opportunity
Position: Principal Regulatory Affairs Specialist – Business Partnerships
Location: Alameda, CA (On-site)
This position supports strategic global business initiatives related to:
Cloud/Sensor-based partnerships
Breakthrough diabetes management solutions
Digital health technologies
The role has department-level influence and involves:
Developing regulatory strategies
Leading submissions for on-market and new products
Acting as a liaison with regulatory agencies, trade associations, and Abbott leadership
Providing regulatory insights and metrics to executive management
Key Responsibilities
Regulatory Strategy & Leadership
Develop global regulatory strategies for product development and lifecycle management.
Analyze outcomes vs. initial concepts and recommend future strategic actions.
Anticipate and address regulatory challenges across product lifecycles.
Provide technical leadership on complex regulatory issues.
Lead creation of project plans and timelines.
Documentation & Compliance
Support teams in generating data for regulatory submissions.
Write, review, and edit technical documentation.
Review and approve labeling and marketing materials for regulatory compliance.
Ensure adherence to post-marketing approval requirements.
Maintain compliance with 21 CFR 820, ISO 13485, and MDD/IVDD directives.
Process Improvement & Risk Management
Oversee and improve regulatory processes related to business partnerships.
Evaluate regulatory risks in corporate policies and initiatives.
Contribute to crisis/issue management programs.
Develop and manage SOPs to track and handle product-associated events.
Provide input for recall communications and compliance actions.
Liaison & Communication
Act as a regulatory liaison between internal and external stakeholders.
Monitor emerging global regulatory trends and propose compliant solutions.
Interface with regulatory authorities to ensure smooth approvals.
Required Qualifications
Bachelor’s Degree in a scientific discipline (e.g., Chemistry, Life Sciences, Biology) or equivalent vocational qualification.
Experience with regulatory submissions for pharmaceuticals, in vitro diagnostics, or medical devices.
Working knowledge of:
21 CFR 820
ISO 13485
Medical Device Directive (93/42/EEC)
IVD Directive (98/79/EC)
Preferred Qualifications
5+ years experience with Class II / Class III medical devices and/or biologics/drugs.
Regulatory Affairs Certification (RAC) preferred.
Experience with:
510(k) applications and PMA supplements
US, EU, and international regulatory submissions
Quality Systems, clinical investigations, and ICH guidelines
Skilled with Microsoft Office Suite and document management systems.
Proven ability to work in cross-functional, global teams.
Strong communication, leadership, and problem-solving abilities.
Excellent time management and attention to detail.
Willingness to travel up to 5% (domestic/international).
Compensation
Base Pay Range: $98,000 – $196,000 (may vary by location).
Application Details
Learn more about Abbott’s benefits at www.abbottbenefits.com.
Follow Abbott on:
Website: www.abbott.com
Facebook: facebook.com/Abbott
Twitter: @AbbottNews, @AbbottGlobal
Abbott is an Equal Opportunity Employer committed to diversity and inclusion.
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