Confidential · 21 hours ago
Regulatory Affairs Specialist
Charlotte, NC
Contract
Onsite
Entry, Mid Level
$44/hr - $53/hr
2+ years expConfidential company is seeking a Regulatory Affairs Specialist to execute established regulatory strategies that support successful global registrations and ongoing lifecycle management of innovative medical devices. The role involves supporting regulatory compliance and submission activities, contributing across a range of projects and global programs.
Marketing & Advertising
Hiring Manager
Sayyad Kamarali
Responsibilities
Review and approve labeling, labeling changes, training, and promotional materials to ensure regulatory compliance
Review change notices and change orders, assessing regulatory impact to U.S. and international regulatory strategies and submissions
Support product and shipping release activities in alignment with regulatory requirements
Maintain and update FDA’s GUDID database
Review and support updates to technical files and external standards
Support internal and global product registrations, including preparation and maintenance of required registration documentation
Respond to government and regulatory authority inquiries and support global registration documentation requirements
Support post-market regulatory compliance activities for U.S. and international product approvals
Assist in the development, implementation, and maintenance of Regulatory Affairs procedures
Ensure compliance with applicable FDA and international regulatory laws, standards, and guidance
Verify compliance with relevant ISO standards and FDA export requirements, as applicable
Coordinate and prepare documentation packages for regulatory submissions, internal audits, and regulatory inspections
Ensure all materials meet requirements for submissions, license renewals, and annual registrations
Stay current on evolving regulatory requirements, procedures, and guidance
Provide regulatory support to Customer Service as needed
Qualification
Required
Bachelor's degree required (a combination of relevant education and experience may be considered)
Minimum of 2 years of Regulatory Affairs experience within the medical device industry
Working knowledge of applicable U.S. and international regulations, standards, and guidance
Proven experience interacting successfully with global regulatory authorities
Knowledge of FDA regulations, MDD, and EU MDR requirements
Strong computer proficiency, including MS Outlook, Word, Excel, and PowerPoint, as well as web-based research tools; ability to quickly learn new software and systems
Preferred
Regulatory Affairs Certification (RAC)
Experience or exposure to pharmaceutical regulations
Familiarity with ISO regulations and standards, including ISO 10993 (biocompatibility)
Company
Confidential
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Silicon Valley, California US, US
51-200 employeesFunding
Current Stage
Growth StageLeadership Team
Roshan Syed
Global Talent Partner
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