Temporary
Regulatory Affairs Specialist
Competitive
Strong documentation, organizational, and communication skillsScience & PharmaceuticalPosted 26d ago
You'll complete your application on the employer's website.
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Role overview
Job type
Salary
Competitive
Sector
Posted
26 days ago
Job description
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
Benefits
Benefit offerings available for associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan.
Associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law.
Holiday pay where applicable.
Glassdoor
3.4
Talent solutions and advisory for organizations and professionals.
Jacksonville, Florida, USA
http://www.lhh.com
Late Stage
Leadership Team
Dave Hilbig
President & CEO, OCM-LHH Utah, Wyoming
Ted Diven, MBA
CEO - OCM / Lee Hecht Harrison (ID, MT, NV)
Recent News
Morningstar.com
LHH Maps Where Laid-Off Workers Move Next: New Data on 418,000 Layoffs Shows 58% Pivot to New Job Functions
2026-09-16
Newswire
LHH Wins Career Development Innovation Award at Inaugural 2026 HR Tech Breakthrough Awards for LHH Career Studio
2026-08-14
24-7 Press Release Newswire
Marquis Who's Who Honors Kathleen Pollard Ochab for Expertise in Personal Development Consulting
2025-05-17
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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
This position is open to candidates residing in California who have prior experience in the medical device industry
Required skills
Represents the skills you have, click on the tags, Medical Device Regulatory Affairs, Medical Device Compliance
Experience
Mid level
Interested in this role?
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