Regulatory Affairs Specialist

Concord

Regulatory Affairs Specialist I Pacheco, CA (Onsite) $35--$40 per hour Temp to Perm \| Monday--Friday, 8:00 a.m.--5:00 p.m. **About the Role** LHH is seeking a Regulatory Affairs Specialist I to support global regulatory compliance for our innovative IVD product portfolio. This early‑career role is ideal for candidates looking to gain hands-on regulatory experience while collaborating with cross-functional teams across R\&D, Quality, and Operations Under the guidance of senior regulatory staff, you will help prepare and maintain regulatory documentation, support international product registrations, and contribute to post-market regulatory activities. If you're detail-oriented, motivated to learn, and eager to grow in the medical device and IVD regulatory space, we'd love to meet yo**u.** **Key Responsibilit**ies * Assist in preparing and submitting regulatory documentation for product registrations in global markets (U.S., EU, Canada, LATAM, APAC). * Maintain regulatory technical documentation, including technical files, GSPR checklists, and supporting records. * Collaborate with internal teams to gather information for submissions, labeling updates, and change documentation. * Support compliance efforts related to ISO 13485, MDSAP, and GMP/QSR requirements. * Assist with risk management documentation, complaint evaluations, and nonconformance investigations. * Support post‑market activities, including MDR, vigilance reporting, advisory notices, and recall documentation. * Conduct regulatory research and summarize global regulatory requirements. * Track and maintain product registrations, listings, renewals, and submission timelines. * Review labeling, IFUs, SDSs, and packaging components for regulatory accuracy. * Maintain regulatory databases, records, and trackers. * Assist in Post‑Market Surveillance data collection, analysis, and documentation. * Support audits, inspections, and regulatory assessments by organizing documentation and responses. * Assist with change control assessments and implementation. * Coordinate with external regulatory consultants or local agents. * Participate in continuous improvement initiatives within Regulatory Affairs. * Perform other duties as assign**ed.** **Qualificat**ions Required: Bachelor's degree in a scientific, engineering, regulatory, or related field OR equivalent experie nce.1--3 years of experience in a regulated medical device, IVD, pharmaceutical, or life sciences environment. Authorization to work in the United States. Preferred / Helpful: Basic understanding of medical device or IVD regulatory frameworks. Familiarity with FDA regulations, EU IVDR, or international regulatory standards. Knowledge of ISO 13485 and risk management principles. Strong attention to detail and organizational skills. Effective written and verbal communication abilities. Experience with document management systems or eQMS tools (a plus). Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy 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