Winston-Salem, North Carolina, United States · On-site
What we are looking for: Plans, organizes and implements strategies and activities required to procure regulatory approval for new and revised product lines. Coordinates and prepares regulatory submissions, including 510…
Skills: Regulatory Submissions, 510(k) Premarket Notifications, EU MDR 2017/745, Technical Documentation, FDA Regulations
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The role involves planning and implementing strategies to obtain regulatory approvals for medical devices, including preparing 510(k) and EU MDR submissions. The specialist also monitors global regulatory changes and provides guidance to product development teams to ensure compliance throughout the design process.
Candidates must have a bachelor's degree in life sciences or engineering and 3-5 years of medical device regulatory experience. Proficiency in US FDA regulations, EU MDR, and ISO 13485 is required, with a strong preference for RAC certification.
Plans, organizes and implements strategies and activities required to procure regulatory approval for new and revised product lines. Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and international requirements and company policies and procedures regarding submissions and other requirements for market approval of medical devices.
Solesis is an innovative provider of biomaterials solutions and services primarily focused on the MedTech and Life Science industries. Through integrated research, development, and manufacturing capabilities, the Solesis family of companies—Charter Medical, Polyzen, and Secant Group—enable technologies and therapies for next-generation patient care. Solesis employs more than 500 people across seven production facilities located in Costa Rica, North Carolina and Pennsylvania.
Offices: 551 E. Church Ave., Telford, Pennsylvania 18969, US
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