Regulatory Affairs Associate
Akkodis Group Nordics, Santa Clara, CA, United States
Akkodis is seeking a
Regulatory Affairs Associate
for a Contract with a client in Santa Clara, CA. The ideal candidate will oversee 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.
Responsibilities
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.
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.
Benefits 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.
Fair Chance & Legal Compliance
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.
#J-18808-Ljbffr
Regulatory Affairs Associate
for a Contract with a client in Santa Clara, CA. The ideal candidate will oversee 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.
Responsibilities
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.
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.
Benefits 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.
Fair Chance & Legal Compliance
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.
#J-18808-Ljbffr