Regulatory Specialist

Our client, a leading organization in the medical device industry, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will be part of the Regulatory Affairs Operations team supporting international labeling and compliance initiatives. The ideal candidate will have strong regulatory knowledge, excellent project management skills, and the ability to collaborate effectively across diverse teams and geographies, which will align successfully in the organization. Job Title: Regulatory Specialist Location: Santa Clara, CA What’s the Job? Lead and execute international addendum labeling requests, including Instructions for Use (IFUs), import labeling, and supplemental labeling. Manage project plans, timelines, and stakeholder communications to ensure timely and compliant implementation of labeling changes. Assess regulatory and quality system requirements to develop compliant labeling strategies for complex product portfolios. Collaborate with cross-functional teams across Regulatory Affairs, Quality, Supply Chain, and Manufacturing to drive alignment and resolve issues. Monitor emerging regulations and translate regulatory requirements into operational processes to ensure ongoing compliance. What’s Needed? Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or related field. Minimum of 6 years of experience in Regulatory Affairs, Regulatory Operations, Quality, or Compliance within a regulated industry. Significant experience with medical devices, pharmaceuticals, or biotechnology products. Proven ability to develop regulatory labeling strategies and lead complex post-approval initiatives. Strong project management skills, including managing timelines, risks, and stakeholder expectations. What’s in it for me? Opportunity to work on impactful projects within a global organization. Collaborate with diverse and talented teams across multiple functions. Develop your expertise in regulatory labeling and compliance strategies. Be part of a company committed to continuous improvement and innovation. Contribute to the success of a leading organization in the medical device industry. Upon completion of waiting period, consultants are eligible for: Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account Health Flexible Spending Account Dependent Care Flexible Spending Account Supplemental Life Insurance Short Term and Long Term Disability Insurance Business Travel Insurance 401(k), Plus Match Weekly Pay #J-18808-Ljbffr ManpowerGroup Global, Inc.