Senior Global Regulatory Operations Lead (Tender)

Abbott

Santa Clara (CA)

On-site

USD 110,000 - 140,000

Full time

14 days+
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Benefits offered by this job

Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account
Flexible Spending Accounts
Life Insurance
Short Term Disability
Long Term Disability
401(k)

Job summary

Abbott is seeking a Regulatory Specialist Sr in Santa Clara, CA, onsite for a 12-month assignment. The role emphasizes independent, cross-functional leadership to manage complex tender regulatory deliverables and global regulatory submissions.

You will collaborate with regulatory, quality, supply chain, legal, and international affiliates to ensure timely, compliant results. The ideal candidate has proven regulatory affairs experience and strong project management capabilities, with a focus on

Qualifications

  • Proven experience in Regulatory Affairs, Regulatory Operations, or international submissions.
  • Advanced project management, prioritization, and organizational skills.
  • Strong ability to lead cross-functional initiatives independently.

Responsibilities

  • Lead end-to-end global tender regulatory deliverables including regulatory docs, certifications, and product compliance data.
  • Coordinate inputs across SMEs and international affiliates, manufacturing, quality, packaging, R&D, and labeling teams.
  • Develop and manage tender trackers, timelines, and governance to ensure on-time execution.
  • Identify risks, elevate issues, and implement mitigation to ensure tender success and timeliness.
  • Ensure compliance with regional and country-specific regulatory requirements and monitor KPIs.

Skills

Regulatory affairs
Cross-functional leadership
Stakeholder management
Documentation oversight
Problem solving
Independent work

Education

Bachelor's degree in Life Sciences

Job description

Abbott is seeking a Regulatory Specialist Sr in Santa Clara, CA, onsite for a 12-month assignment. The role emphasizes independent, cross-functional leadership to manage complex tender regulatory deliverables and global regulatory submissions.

You will collaborate with regulatory, quality, supply chain, legal, and international affiliates to ensure timely, compliant results. The ideal candidate has proven regulatory affairs experience and strong project management capabilities, with a focus on

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