Regulatory Affairs Associate

Abbott; Santa Clara (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Regulatory Affairs Associate in Santa Clara, California. This role involves monitoring global regulatory changes, implementing compliance procedures, and managing product registration processes. The ideal candidate will have experience in Quality Systems or Compliance roles, ensuring that all regulatory requirements are met effectively.

Qualifications

• Experience with Quality Systems or Compliance roles is advantageous.

Responsibilities

• Monitor changing regulations and translate requirements into the quality system.
• Implement new international regulatory requirements and ensure compliance.
• Manage international submission deliverables for product registration renewals.

Skills

Regulatory Compliance

Quality Systems

Job description

Title: Regulatory Affairs Associate

Location: Santa Clara, California

Duration: 6 Months

Work Arrangement: 100% Onsite

Responsibilities:

1. Monitor changing regulations and emerging regulatory issues globally, translating requirements into the quality system.
2. Implement new international regulatory requirements, ensuring procedures are current and compliant.
3. Manage international submission deliverables for product registration renewals and regulatory issues, including maintaining trackers for Declarations of Conformity and ensuring compliance with local requirements.
4. Drive quality system process improvement initiatives.

Additional Initiatives include:

1. Establishing emerging issues within the quality system.
2. Maintaining quality system procedures (e.g., change management).
3. Liaising with cross-functional partners, distribution centers, and international affiliates to align on regulatory requirements.
4. Troubleshooting with regulatory affiliates and participating in RA projects.

List of Tasks:

1. Handling CFG requests in the FDA database.
2. Managing Declarations of Conformity.
3. Reviewing Regulatory Letters and maintaining trackers for LoA / PoA.
4. Coordinating pan-franchise requests for multiple products and scheduling meetings with international requesters.
5. Maintaining trackers, SharePoint sites, and folders to track current status.
6. Supporting change management processes.

This role may involve investigating non-conformances (CAPAs) and implementing mitigations. Experience with Quality Systems or Compliance roles is advantageous.