Regulatory Affairs Associate

Akkodis is seeking a Regulatory Affairs Associate for a Contract with a client in Santa Clara, CA. The ideal candidate will develop and manage regulatory-compliant medical device labeling, including IFUs, product labels, and country-specific addendums while coordinating cross-functional stakeholders to ensure timely implementation. Rate Range: $40/Hour to $45/Hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Regulatory Affairs Associate Responsibilities include:

• Develop, review, and maintain medical device labeling, including IFUs, product labels, import labels, and country-specific addendums.
• Collaborate with Regulatory Affairs, international affiliates, and cross-functional teams to ensure labeling compliance and accuracy.
• Manage labeling change projects, coordinate timelines, and support multiple concurrent regulatory initiatives.
• Monitor global regulatory requirements and implement labeling updates to maintain compliance with FDA and international standards.
• Prepare and submit labeling documentation, SAP packages, and supporting materials for release and implementation.
• Maintain labeling records, support audits, track project metrics, and troubleshoot labeling-related issues through resolution.

Required Qualifications:

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.
• Minimum 4+ years of experience in a regulated industry, preferably within medical devices, regulatory affairs, quality, or labeling operations.
• Proven experience in medical device labeling design, development, and implementation with a strong understanding of FDA and international regulatory requirements.
• Proficiency in SAP, document management systems, and Microsoft Office, with experience managing labeling documentation and change control processes.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at Udbhav.Mathur@modis.com.

Pay Details: $40.00 to $45.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, 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.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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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

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.