Regulatory Affairs Specialist

Job Summary

Leading regulatory strategy for innovative Class III implantable devices, the remote Regulatory Affairs Specialist will prepare, review, and maintain regulatory submissions while supporting product lifecycle management from development through post-market activities.

Key responsibilities:

• Prepare, review, and submit US regulatory documentation, including IDEs, PMAs, and 510(k) submissions
• Collaborate with global regulatory colleagues to align submission strategies and ensure compliance with FDA regulations
• Monitor changes in US regulatory requirements and assess their impact on products and documentation

Required qualifications:

• Bachelor's degree in Regulatory Affairs, Biology, Biomedical Engineering, Life Sciences, or a related field
• Experience preparing, reviewing, and submitting regulatory documentation for Class III medical devices
• Strong understanding of US FDA regulatory pathways, including PMA and/or 510(k) processes
• Familiarity with ISO 13485, ISO 14971, and FDA Quality System Regulations (QSR)
• Experience working with CROs or external partners for regulatory submissions