Regulatory Affairs Specialist

Akkodis is seeking Regulatory Affairs Specialist in Santa Clara CA 95054. Ideally, looking for someone with Minimum 6 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Compliance, Labeling, or related functions within a regulated industry.

Rate Range: $50/hour to $52/hour on w2. The rate may be negotiable based on experience, education, geographic location, and other factors.

JOB RESPONSIBILITIES:

• Lead and execute addendum labeling requests for country-specific Instructions for Use (IFUs), import labeling, product-specific addendum labeling, and supplemental labeling, including preparation, review, and coordination of Universal Addendum Labeling (UAL) packages and supporting documentation.

• Own addendum labeling requests from initiation through implementation and release, developing and managing project plans, timelines, priorities, forecasts, and stakeholder communications to ensure on-time execution.

• Assess and apply regulatory, quality system, and business requirements to develop compliant addendum labeling strategies for complex product portfolios across multiple quality systems.

• Perform regulatory and quality system assessments for complex addendum labeling requests to determine implementation pathways, ownership, approvals, regulatory strategy, and compliance requirements, providing recommendations to support successful market implementation.

• Influence and collaborate with cross-functional stakeholders across Regulatory Affairs, Quality, Supply Chain, Manufacturing, and international affiliates to drive alignment, resolve issues, identify risks, communicate impacts, and escalate issues as needed to support business objectives and compliance requirements.

• Develop and improve addendum labeling procedures, work instructions, operational processes, and quality system integrations, while driving continuous improvement initiatives to improve compliance, efficiency, and scalability.

• Monitor emerging regulations and regulatory changes, evaluate potential impacts on labeling requirements and processes, and translate regulatory requirements into operational and quality system processes.

• Maintain project metrics, dashboards, forecasts, and status updates to support operational planning, resource allocation, and management reporting.

QUALIFICATIONS:

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, Engineering, or related discipline.

• Minimum 6 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Compliance, Labeling, or related functions within a regulated industry.

• Significant experience in medical devices, pharmaceuticals, biotechnology, or combination products.

• Experience developing regulatory labeling strategies and leading complex post-approval labeling initiatives.

• Demonstrated experience managing cross-functional projects and successfully delivering results in global organizations.

• Experience owning labeling processes, change management activities, and process improvement initiatives.

• Proven ability to develop project plans, manage timelines, forecast workloads, and drive execution.

• Experience identifying risks, developing mitigation plans, and escalating critical issues appropriately.

• Strong knowledge of medical device quality systems and regulatory requirements.

• Excellent communication, stakeholder management, negotiation, and collaboration skills.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, If you have questions about the position, please contact Mohammed Irfan Murtuza at irfan.murtuza@akkodisgroup.com

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.

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