Regulatory Specialist

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

Jun 17, 2025 - 22:30

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