Regulatory Affairs Specialist

Akkodis is seeking a Regulatory Affairs Operations Specialist for a 12-month contract with a client in Santa Clara CA 95054.

Title: Regulatory Affairs Operations Specialist

Location: Santa Clara CA 95054

Duration: 12-month Contract

Pay Rate: $42-$44/hr on w2 (The rate may be negotiable based on experience, education, geographic location, and other factors.)

Job Summary

We are seeking a detail-oriented and proactive Regulatory Affairs Operations Specialist to support our Regulatory Affairs team. This role plays a key part in ensuring compliance with international regulatory requirements, maintaining high-quality documentation standards, and supporting cross-functional initiatives across global markets.

Summary of Responsibilities:

The Regulatory Affairs Operations specialist will provide support to the Regulatory Affairs organization by –

• Drive implementation of new international regulatory requirements, ensuring procedures are current and compliant with applicable guidance and requirements.

• Lead quality system process improvement initiatives

• Prepare KPI dashboards and maintaining a pulse on internal Regulatory Affairs (RA) metrics.

• Coordinate pan-franchise requests for multiple products, including scheduling and facilitating meetings with international stakeholders

• Submit and track addendum labeling requests.

• Liaise with cross-functional partners, distribution centers, and international affiliates to align on regulatory requirements, documentation, addendum labeling, and regulatory letters.

Pan Franchise Specialist – Santa Clara

Key tasks and Initiatives:

Initiatives include but are not limited to:

• Prepare and submit certificates to Foreign Governments (CFG) requests via the FDA database.

• Maintain tracker and review Declarations of conformity (DoC):

- Ensure adherence to Good Documentation Practices (GDP)

- Manage translation requests using the Acolad portal

- Review EU MDR DoC translations for accuracy and consistency

• Review Regulatory Letters and maintain tracker for Letter of Authorization (LoA), Power of Attorney (PoA), tenders, controlled substances and evidence of conformance letters.

• Maintain up-to-date trackers, SharePoint sites, and documentation repositories

• Support change management activities, including change orders (CO) for DoC templates and quality system procedures

• Establishing emerging issues within the quality system,

• Participate in RA projects and continuous improvement initiatives

• Troubleshoot regulatory issues in collaboration with international regulatory affiliates

This 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.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance