Sr Regulatory Affairs Specialist

Akkodis is seeking a Sr Regulatory Specialist for a 12-month contract with a client in Santa Clara, CA 95054 (100% Onsite). Title: Sr Regulatory Specialist Duration: 12-month contract with possible extension Pay Rate: $50-52/hr (The rate may be negotiable based on experience, education, geographic location, and other factors. Job Description Description / Summary We are seeking a highly skilled and experienced Regulatory Affairs Senior Specialist to join the Regulatory Affairs Operations team. This individual will serve as a key contributor to the centralized execution of international addendum labeling activities across Clients Vascular's medical device portfolio. This role will lead complex addendum and supplemental labeling initiatives, partnering with Regulatory Affairs, Quality, Supply Chain, Packaging, Manufacturing, and international affiliates to ensure timely and compliant implementation of labeling changes. The ideal candidate will possess strong regulatory and quality system knowledge, project management capabilities, and the ability to influence stakeholders across multiple functions, geographies, and business environments. This individual must be comfortable operating independently, managing competing priorities, identifying risks, driving escalations, and developing addendum labeling strategies. Minimum Qualifications Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, Engineering, or related discipline. Minimum 6 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Compliance, Labeling, or related functions within a regulated industry. Significant experience in medical devices, pharmaceuticals, biotechnology, or combination products. Experience developing regulatory labeling strategies and leading complex post-approval labeling initiatives. Demonstrated experience managing cross-functional projects and successfully delivering results in global organizations. Experience owning labeling processes, change management activities, and process improvement initiatives. Proven ability to develop project plans, manage timelines, forecast workloads, and drive execution. Experience identifying risks, developing mitigation plans, and escalating critical issues appropriately. Strong knowledge of medical device quality systems and regulatory requirements. Excellent communication, stakeholder management, negotiation, and collaboration skills. If you are interested in this job, please get in touch with Udbhav Mathur at View email address on click.appcast.io. 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 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 #J-18808-Ljbffr Akkodis