Job Description
Title: Regulatory Affairs Associate
Location: Santa Clara, CA
Duration: 12Months
100% Onsite
Summary
We are seeking a Regulatory Affairs & Quality Specialist with experience in medical devices and international regulations. This role involves handling regulatory submissions, interpreting letters from multiple countries, supporting cross-functional teams, and ensuring compliance with quality and documentation standards.
Key Responsibilities
- Manage regulatory submissions, approvals, and letters across multiple countries
- Interpret regulatory letters and ensure proper actions are taken
- Support document control, change orders, and quality system procedures
- Navigate international regulatory requirements and support multiple franchises
- Provide critical thinking and problem-solving for regulatory and quality issues
- Maintain trackers, documentation repositories, and ensure compliance with standards
Qualifications
- Background in Regulatory Affairs and Quality for medical devices
- Experience with international regulatory processes and approvals
- Strong critical thinking and problem-solving skills
- Ability to handle document control, change orders, and franchise support
- Strong organizational skills; ability to work independently.
Consultants Eligible Benefits Upon Waiting Period
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High-Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.