Regulatory Affairs Associate

Akkodis is seeking a Regulatory Affairs Associate for a Contract with a client in Santa Clara, CA. The ideal candidate who oversees labeling changes and regulatory submissions to support compliant approval of 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

• Manage and execute regulatory submissions for Class III implantable medical devices, including authoring and submitting PMA supplements (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.
• Serve as the primary regulatory liaison with the FDA and other government agencies, handling inquiries and maintaining ongoing communication.
• Review and approve engineering, validation, and manufacturing change documentation to ensure regulatory compliance.
• Provide regulatory guidance on study protocols, reports, and quality system requirements within a regulated medical device environment.
• Mentor and guide cross-functional teams by applying regulatory expertise, judgment, and creativity to support product lifecycle objectives.
  
  

Required Qualifications

• Bachelor’s degree in a scientific, engineering, or related discipline preferred.
• Minimum of 5 years of experience in Regulatory Affairs within a medical device or regulated industry.
• Demonstrated hands-on experience with regulatory labeling and successful authoring, submission, and approval of Class III implantable device PMA supplements.
• Strong knowledge of FDA PMA regulations, CFR requirements, and quality systems, with the ability to independently manage regulatory interactions and approvals.
  
  

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

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

Requirements

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.