Regulatory Specialist

Job Summary

A company is looking for a Regulatory Specialist to support product development and ensure compliance with regulatory requirements.

Key Responsibilities

• Plan and coordinate processes related to product regulatory approval, including FDA clearance and CE Marking
• Collaborate with engineering and product teams to ensure regulatory compliance for product markets
• Create and maintain technical documentation for regulatory approval and support clinical studies

Required Qualifications, Training, and Education

• Bachelor's degree in a relevant field or equivalent experience
• Knowledge of Medical Devices Regulations (MDR), ISO standards, and MDSAP
• 2 - 4 years of experience in a regulated industry, preferably with FDA and Software as a Medical Device
• Experience drafting and submitting various regulatory filings and interacting with Regulatory Authorities
• Understanding of pre- and post-market clinical studies and relevant regulations