Regulatory Affairs Associate

Title: Regulatory Affairs Associate

Location: Santa Clara, California

Duration: 12+ Months

100% Onsite

Description / Summary:

• This role will provide support to the Regulatory Affairs organization by –
• Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system,
• Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidances are met,
• Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission, including maintaining tracker of Declarations of Conformity, confirming against local requirements, and driving to issuance.
• Driving quality system process improvement initiatives

Initiatives include but are not limited to:

• Establishing emerging issues in our quality system,
• Maintaining the quality system procedures (e.g. change management),
• Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements,
• Troubleshooting with regulatory affiliates, and
• Participating in RA projects.
• Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.

List of tasks:

• CFG requests in the FDA database.
• Declarations of conformity.
• Review Regulatory Letters and maintain LoA / PoA tracker.
• Will coordinate pan-franchise requests for multiple products, schedule meetings with international requesters.
• Maintain tracker / SharePoint / folders with current state.
• Change management

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.