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US - Regulatory Affairs Specialist-Sr

Cordova, TN 38018

Posted: 11/13/2025 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 622952 Is job remote?: No Country: United States

Job Description

Pay range: 35-41/hr
*depending on experience

Description:
• Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices.
• Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.
• Manage/lead regulatory-driven project, as directed by management.
• Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products.
• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology.
• Plan, lead and support for internal and Regulatory agency audits
• Lead and direct engagement with regulatory authorities as required
• Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance.
• Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
• Review product labeling to ensure compliance with regulatory requirements
• Other activities as assigned.
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About Cordova, TN

Unlock your potential in Cordova, Tennessee! Discover amazing job opportunities in this vibrant community that blend southern charm with bustling growth. Located in Shelby County, just moments away from Memphis, Cordova offers a perfect mix of small-town appeal and urban convenience. From the iconic Shelby Farms Park, known as one of the largest urban parks in the country, to the delicious Memphis-style barbecue that will tantalize your taste buds, Cordova provides a rich tapestry of cultural experiences. Explore the Cordova Community Center, catch a memorable show at the Germantown Performing Arts Center, or cheer for the Memphis Grizzlies at the FedExForum. Embrace the warmth of Cordova and embark on a career that excites you. Start your journey today by exploring our diverse job listings in this extraordinary region!