🧾 Job Title: Regulatory Affairs Project Manager
Category: Regulatory Affairs
Location: United States – California – Alameda
Organization: Abbott Laboratories
🌍 About Abbott
Abbott is a global healthcare leader helping people live healthier and more fulfilling lives.
Its diverse portfolio includes:
Diagnostics
Medical Devices
Nutritionals
Branded Generic Medicines
With 114,000+ employees across 160+ countries, Abbott is consistently recognized by Fortune and Forbes as:
One of the Most Admired Companies in the World
A Top Employer for diversity, women, scientists, and working mothers
💼 Working at Abbott – Employee Benefits
🌱 Career Growth: Build your dream career through global development opportunities
🏥 Health Coverage: Free medical coverage via the Health Investment Plan (HIP) PPO
💰 Retirement Savings: Excellent employer contribution plan
🎓 Education Support:
Tuition reimbursement
Freedom 2 Save student debt program
FreeU bachelor’s degree benefit program
🌟 Global Recognition: Named among the Best Big Companies to Work For worldwide
🚀 The Opportunity
Abbott is seeking a Regulatory Affairs Project Manager to join the Lingo team based in Alameda, California.
This is an individual contributor role focused on combining scientific, regulatory, and business expertise to ensure that products meet all legislative and regulatory requirements globally.
The Regulatory Affairs Project Manager serves as an expert resource, influences departmental processes, and provides strategic direction for product registration and compliance.
🧭 Key Responsibilities
🔹 Strategic Planning
Develop and implement new regulatory policies, SOPs, and processes; train key personnel accordingly.
Evaluate and manage regulatory risks associated with divisional procedures.
Provide regulatory input into product lifecycle planning and concept evaluation.
Support development of multicountry regulatory strategies and update them as regulations evolve.
Participate in regulatory due diligence for acquisitions and partnerships.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle; develop proactive solutions.
Identify and monitor emerging issues and trade association positions that impact Abbott products.
Mentor and develop junior regulatory professionals.
Determine submission and approval requirements for new products and product changes.
📋 Core Job Responsibilities
Ensure compliance with Abbott corporate and divisional policies.
Utilize technical and regulatory expertise to design strategies for complex product submissions.
Manage preparation of regulatory submissions for global markets (FDA, EU, Health Canada, LATAM, etc.).
Provide regulatory insight to cross-functional teams on clinical studies, labeling, and advertising.
Lead or contribute to regulatory projects and documentation (PMA, IDE, 510(k), Technical Files).
🎓 Required Qualifications
Education:
Bachelor’s degree in Science, Engineering, Medical Technology, Pharmacy, or related field
Advanced degree (M.S., MBA, Ph.D.) preferred
Regulatory certification (e.g., RAC – Regulatory Affairs Certification) is a plus
Experience:
Minimum 4 years in a regulated industry (medical devices, nutritionals, etc.)
2–5 years in Regulatory Affairs preferred
Experience in Quality Assurance, R&D, or Scientific Affairs will be considered
Technical Regulatory Knowledge:
Global and domestic regulatory guidelines, policies, and processes
FDA and international submission/registration requirements
GxPs (GCP, GLP, GMP)
Product promotion, labeling, and advertising regulations
Ethical and legal guidelines in regulatory and clinical research
🧠 Core Competencies
✳️ Communication Skills
Strong verbal and written communication across diverse audiences
Ability to write and edit technical and regulatory documents
Collaborate effectively with cross-functional and cross-cultural teams
Negotiate with regulatory agencies and internal stakeholders
Lead meetings and present regulatory strategies
✳️ Analytical & Cognitive Skills
High attention to detail and accuracy
Strong project management and organizational abilities
Analytical thinker with excellent problem-solving skills
Capable of managing multiple priorities simultaneously
Sound judgment within broad policies and complex regulatory frameworks
Competence in risk assessment and data-driven decision making
🧩 Preferred Qualifications
Experience with LATAM regulatory authorities
Fluency in Spanish preferred
Advanced degree in Engineering, Life Sciences, or related discipline
Experience with:
FDA Class II & III device submissions (PMA, IDE, 510(k))
EU Technical Files and Canada Class III & IV License Applications
8+ years in regulatory or medical device submission preparation
Proven leadership in developing cross-functional project plans
Ability to lead functional teams in creating data for regulatory submissions
💰 Compensation
Base Pay Range:
💵 $112,000 – $224,000
(Actual salary may vary depending on location and experience)
🔗 How to Apply
Visit: www.abbott.com
Explore employee benefits: www.abbottbenefits.com
🤝 Equal Opportunity Statement
Abbott is an Equal Opportunity Employer, committed to diversity, inclusion, and professional growth for all employees.
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