Regulatory Affairs Specialist

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 PST

Assignment Details:

• Contract role
• Remote
• Located in San Diego
• Compensation: $38.00 - $56.00 per hour DOE

If you meet the qualifications and are interested in this opportunity, please apply now — we are conducting interviews immediately!

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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