LHH Recruitment Solutions is seeking a Regulatory Affairs Specialist for a minimum 6-month remote contract opportunity. This position is open to candidates residing in California who have prior experience in the medical device industry. The ideal candidate will have a strong understanding of regulatory requirements, medical device compliance, and regulatory documentation. This role offers an hourly pay range of $38–$56 per hour, depending on experience, with a Monday–Friday schedule from 8:00 AM to 5:00 PM PST.
Responsibilities:
  • Prepare, review, and maintain regulatory submissions and documentation for medical devices in accordance with applicable FDA requirements
  • Support regulatory compliance activities throughout the medical device product lifecycle
  • Review product documentation, labeling, and technical files for accuracy and compliance with regulatory standards
  • Monitor changes to FDA regulations and other applicable medical device regulatory requirements
  • Collaborate with Quality Assurance, Research and Development, and other cross-functional teams to support regulatory initiatives
  • Assist with regulatory audits, inspections, and responses to regulatory inquiries
  • Maintain organized regulatory records and ensure documentation meets internal quality standards
  • Support regulatory strategy and provide guidance on compliance requirements for new and existing products
Qualifications:
  • Previous regulatory affairs experience within the medical device industry is required
  • Knowledge of FDA regulations and medical device regulatory requirements
  • Strong documentation, organizational, and communication skills
  • Ability to manage multiple priorities and meet deadlines in a remote environment
  • Must reside in California and be available to work Monday–Friday, 8:00 AM–5:00 PM PSTAssignment Details:
  • Contract role
  • RemoteLocated in San Diego
Compensation: $38.00 - $56.00 per hour DOEIf you meet the qualifications and are interested in this opportunity, please apply now — we are conducting interviews immediately! 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-privacyThe 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

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Location

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Industry

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Posted

5 days ago

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