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Confidential · 20 hours ago

Regulatory Affairs Specialist

Charlotte, NC

Contract

Onsite

Entry, Mid Level

$44/hr - $53/hr

2+ years exp

Confidential 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

Regulatory Affairs experienceFDA regulationsU.S.International regulationsRegulatory Affairs Certification (RAC)ISO regulations familiarityComputer proficiencyEffective communicationCross-functional collaboration

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

Silicon Valley, California US, US

51-200 employees

Funding

Current Stage

Growth Stage

Leadership Team

Roshan Syed

Global Talent Partner

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