Regulatory Affairs Specialist

Job Description

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

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!

Pay Details: $38.00 to $56.00 per hour

Search managed by: Ciara Norton

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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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

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.