Regulatory Affairs Associate

SupportFinity™; San Jose (CA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Supplemental Life Insurance

Short Term Disability

Long Term Disability

Critical Illness, Hospital coverage, 1

MetLife Legal, MetLife ID Fraud, and 1

401(k)

Job summary

Abbott is a global healthcare leader seeking a Regulatory Affairs Associate to support regulatory submissions and interpret letters across multiple countries. The role emphasizes quality system procedures, document control, and cross-functional collaboration to ensure compliance across franchises.

This onsite opportunity in Santa Clara, CA focuses on international regulatory requirements, problem solving, and maintaining accurate trackers and repositories to uphold high 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.

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

Skills

Regulatory affairs

Quality management

Critical thinking

Documentation control

Independent work

Job description

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.

Title

Regulatory Affairs Associate

Location

Santa Clara, CA

Duration

12Months

100% Onsite

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.

About the company

Abbott