LHH · 13 hours ago
Regulatory Affairs Specialist
Concord, CA
Full-time
Onsite
New Grad, Entry Level
$35/hr - $45/hrLHH is a company seeking a Regulatory Affairs Specialist to support global regulatory activities for a diagnostic product portfolio. This role assists with regulatory documentation, product registrations, and compliance throughout the product lifecycle.
Human Resources
Responsibilities
Assist with preparing, compiling, and submitting regulatory documentation for global product registrations across multiple regions
Support the upkeep of regulatory technical documentation, including files, checklists, and supporting records
Work with cross‑functional groups such as R&D, Quality, and Operations to collect information for submissions, labeling updates, and change documentation
Assist with compliance efforts related to quality system requirements and international regulatory standards
Support risk‑management activities including documentation updates, complaint evaluations, and investigation assistance
Contribute to post‑market regulatory tasks such as reporting, notices, and related documentation
Conduct regulatory research and summarize requirements for review by senior staff
Support international registrations, listings, licensing, and renewals, including tracking deadlines and submission status
Assist with reviewing labeling, instructions for use, safety documents, and packaging for regulatory accuracy
Maintain regulatory records, databases, and submission trackers
Support post‑market surveillance activities including trend analysis and documentation preparation
Participate in internal audits, inspections, and assessments by organizing documentation and assisting with responses
Support regulatory change‑control activities and impact assessments
Assist with coordination of external regulatory consultants or representatives
Contribute to process improvement activities within the regulatory function
Perform additional duties as assigned
Qualification
Required
Assist with preparing, compiling, and submitting regulatory documentation for global product registrations across multiple regions
Support the upkeep of regulatory technical documentation, including files, checklists, and supporting records
Work with cross‑functional groups such as R&D, Quality, and Operations to collect information for submissions, labeling updates, and change documentation
Assist with compliance efforts related to quality system requirements and international regulatory standards
Support risk‑management activities including documentation updates, complaint evaluations, and investigation assistance
Contribute to post‑market regulatory tasks such as reporting, notices, and related documentation
Conduct regulatory research and summarize requirements for review by senior staff
Support international registrations, listings, licensing, and renewals, including tracking deadlines and submission status
Assist with reviewing labeling, instructions for use, safety documents, and packaging for regulatory accuracy
Maintain regulatory records, databases, and submission trackers
Support post‑market surveillance activities including trend analysis and documentation preparation
Participate in internal audits, inspections, and assessments by organizing documentation and assisting with responses
Support regulatory change‑control activities and impact assessments
Assist with coordination of external regulatory consultants or representatives
Contribute to process improvement activities within the regulatory function
Perform additional duties as assigned
Foundational understanding of regulatory requirements for medical devices or diagnostics
Exposure to FDA, EU, or other international regulatory frameworks (academic or early career experience acceptable)
Strong attention to detail and organizational skills
Ability to manage multiple tasks with guidance
Effective written and verbal communication skills
Willingness to learn regulatory procedures and standards
Preferred
Familiarity with quality management standards and risk‑management principles is preferred
Experience with document‑management or electronic quality systems is helpful but not required
Benefits
Medical
Dental
Vision
Life insurance
Short-term disability
Additional voluntary benefits
EAP program
Commuter benefits
401K plan
Paid Sick Leave
Holiday pay
Company
LHH
At LHH, we believe work should be meaningful, fulfilling, and connected.
Founded in 1967
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Dave Hilbig
President & CEO, OCM-LHH Utah, Wyoming
Ted Diven, MBA
CEO - OCM / Lee Hecht Harrison (ID, MT, NV)
Recent News
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2025-05-17
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