Senior Regulatory Affairs Specialist

Key Responsibilities: Prepare, coordinate, and manage regulatory submission documentation, including 510(k) submissions and EU MDR technical documentation. Develop regulatory submission strategies to support product approvals and market access. Compile documentation for regulatory submissions, license renewals, annual registrations, audits, and inspections. Evaluate labeling, manufacturing, marketing, and clinical documentation for regulatory compliance. Monitor regulatory requirements, guidance, and changes in applicable standards. Collaborate cross-functionally with Engineering, Quality, Clinical, and other stakeholders to achieve regulatory objectives. Identify opportunities to improve regulatory processes, documentation, and tracking systems. Provide regulatory guidance and recommendations to support timely approvals.

Required Qualifications: Bachelor’s degree in a scientific discipline or equivalent. 5–8 years of relevant regulatory affairs experience. Demonstrated experience developing and writing 510(k) and EU MDR submissions, including regulatory strategy. Experience with electrical medical devices and IEC 60601 standards. Strong written and verbal communication skills. Proven ability to work independently, take ownership of deliverables, and collaborate effectively across cross-functional teams. Position DetailsLocation: Jacksonville, FL preferred; remote candidates may be considered based on experience.

Schedule: Full-time, 40 hours per week.

Position Type: Contract. If you have strong medical device regulatory affairs experience and a background in 510(k) submissions, EU MDR, and IEC 60601, we’d like to hear from you!