Senior Regulatory Affairs Specialist

Akkodis is seeking a Senior Regulatory Affairs Specialist for a Contract with a client in Santa Clara, CA. The ideal candidate will support regulatory affairs operations by collaborating with cross-functional teams to develop and improve regulatory processes and product submissions. Rate Range: $60/Hour to $64/Hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Senior Regulatory Affairs Specialist Responsibilities include:

• Develop, update, and improve regulatory affairs processes across multiple business units.
• Support product registration submissions, supplements, amendments, and periodic reports.
• Collaborate with cross-functional teams to ensure regulatory compliance and submission readiness.
• Maintain and revise regulatory procedures to align with evolving requirements, including MDR.
• Conduct regulatory change assessments and provide guidance on compliance impacts.
• Identify process improvement opportunities and drive regulatory initiatives through completion.

Required Qualifications:

• Bachelor's degree required, preferably in a scientific, engineering, or related field.
• 3-5 years of experience in Medical Device Regulatory Affairs.
• Working knowledge of MDR, Regulatory Change Assessments, and medical device submission processes.
• Experience supporting internal and external regulatory inspections and audits.

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: $60.00 to $64.00 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

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.