Regulatory Affairs Specialist

LHH; San Diego (CA); Remote; USD 52,000 - 77,000; Part time

Job summary

LHH Recruitment Solutions is seeking a Regulatory Affairs Specialist for a minimum 6-month remote contract opportunity. This role requires residency in California and prior medical device regulatory experience, with an emphasis on FDA regulations and regulatory documentation.

The position is remote with a Monday–Friday schedule from 8:00 AM to 5:00 PM PST, and compensation is $38–$56 per hour DOE. Located in San Diego, CA, this contract role offers flexible remote work within CA.

Qualifications

• Regulatory affairs experience in the medical device industry is required.
• Knowledge of FDA regulations and medical device regulatory requirements.
• Strong documentation and record-keeping skills.
• Ability to work remotely and manage multiple priorities.
• Must reside in California and be available Mon–Fri, 8:00 AM–5:00 PM PST.
• Contract role; remote; located in California (San Diego).

Responsibilities

• Prepare, review, and maintain regulatory submissions and documentation for medical devices per FDA requirements.
• Support regulatory compliance throughout the product lifecycle.
• Review product labeling, technical files, and documentation for accuracy and compliance.
• Monitor FDA regulation changes and other regulatory requirements.
• Collaborate with QA, R&D, and cross-functional teams on regulatory initiatives.
• Assist with regulatory audits, inspections, and inquiries responses.
• Maintain organized regulatory records and ensure documentation meets internal quality standards.
• Support regulatory strategy and provide compliance guidance for new and existing products.

Skills

Regulatory affairs

FDA regulations

Documentation

Organization

Communication

Remote work

California resident

Job description

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

Equal Opportunity Employer/Veterans/Disabled

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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