Regulatory Affairs Specialist

Job Title: Consultant, Regulatory Affairs Specialist, Medical Device

Duration: This will be 6-month contract to hire opportunity, with an onsite requirement in Charlotte, NC.

Pay rate: PR $44-$60/hr and Salary would be 75-96k once converted

“Please note: This role requires relocation to Charlotte, NC, and candidates should be willing to relocate at their own expense.”

The Work

We are seeking a Regulatory Affairs Specialist to execute established regulatory strategies that support successful global registrations and ongoing lifecycle management of innovative medical devices designed to address unmet patient needs.

As an integral member of the Regulatory Affairs team, you will support both regulatory compliance and submission activities, contributing across a range of projects and global programs. This role requires an intermediate understanding of medical devices, their intended use, and applicable regulatory pathways.

You will bring a strong sense of urgency and ownership to cross-functional collaboration, helping drive regulatory activities forward while ensuring clear, effective communication with internal and external partners worldwide.

Key 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

Qualifications

• 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 Skills:
Regulatory Affairs Certification (RAC)

• Experience or exposure to pharmaceutical regulations


• Familiarity with ISO regulations and standards, including ISO 10993 (biocompatibility)