Job Description

Akkodis is seeking a Regulatory Affairs Associate for a Contract with a client in Santa Clara, CA. The ideal candidate who managing labeling changes and end‑to‑end regulatory submissions to ensure compliance for Class III implantable medical devices.

Rate Range: $43/hour to $45/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Regulatory Affairs Associate Job Responsibilities include:

• Author, submit, and manage PMA supplements for Class III implantable medical devices, including 30‑Day Notices, Real‑Time Reviews, 180‑Day Supplements, and Annual Reports.

• Lead hands-on regulatory labeling activities, including addendum and supplemental labeling and execution of labeling changes in compliance with FDA requirements.

• Act as the primary regulatory liaison, managing all FDA and government agency interactions related to product approvals and regulatory inquiries.

• Review and approve engineering study protocols/reports and validation study documentation to ensure regulatory and quality compliance.

• Review and approve manufacturing changes, assessing regulatory impact and ensuring continued compliance with FDA PMA and CFR regulations.

• Provide regulatory guidance and leadership to cross‑functional teams, applying expertise and judgment to support product lifecycle and compliance objectives.

Required Qualifications:

• Bachelor’s degree in a scientific, engineering, or related discipline.

• Minimum of 5+ years of experience in Regulatory Affairs within a medical device or regulated industry.

• Hands-on experience with regulatory labeling and a proven track record of authoring, submitting, and obtaining approval for Class III implantable device PMA supplements.

• Strong knowledge of FDA PMA guidance, CFR regulations, and quality systems with demonstrated ability to review and approve engineering, validation, and manufacturing changes.

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@ akkodisgroup.com.

Pay Details: $43.00 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.

Job Tags

Hourly pay, Contract work, Temporary work, For contractors, Local area

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