What are the responsibilities and job description for the Regulatory Affairs Specialist position at Akkodis?
About the job:
Akkodis is seeking a Regulatory Project Manager for a contract role. This role supports regulatory activities within a medical device, pharmaceutical, or life sciences environment, focusing on coordination of regulatory deliverables, timelines, and compliance.
Pay Range: $41 - $43/hr on W2 (The pay rate may be negotiable based on experience, education, geographic location, and other factors.)
Responsibilities:
- Manage and track regulatory project timelines and deliverables
- Coordinate with cross-functional teams including R&D, Quality, and Manufacturing
- Support preparation and submission of regulatory documentation
- Ensure compliance with FDA, ISO 13485, and other regulatory standards
- Track risks, issues, and provide updates to stakeholders
- Support change control and product lifecycle management activities
- Maintain regulatory documentation and support audit readiness
Required Skills & Experience:
- Experience in Regulatory Affairs within medical device, pharma, or life sciences
- Strong understanding of FDA regulations and ISO 13485
- Experience managing or coordinating projects and timelines
- Strong communication and stakeholder management skills
- Experience with regulatory documentation and compliance processes
Preferred Qualifications:
- Experience with regulatory submissions (510(k), EU MDR, etc.)
- PMP or project management certification
- Experience in product lifecycle or change management
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 Atal.Rai@akkodisgroup.com
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an 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. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/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
Salary : $41 - $43