Barrington James Limited
Regulatory affairs specialist
Working with an exciting biotech company that has grown by over 75% in the last two years and is looking for a regulatory affair specialist to enhance their team. This company is focusing on pushing the limits of innovation and supply in global health! Key responsibilities
Supporting the preparation, review and correct submission of regulatory documentation for medical device/IVDs products ensuring compliance with all regulatory requirements including FDA, ISO 13485. Help to prepare PMA packages, including nonclinical, manufacturing, and clinical sections. Working on analytical performance test with product development teams to draft documentation Requirements
Bachelor’s degree in regulatory affairs, engineering and life sciences or a health or science related field is required. Professional experience
2+ years of regulatory affairs experience within the medical device or IVD industry. Experience interacting with FDA regulations and guidance (510k). If interested in this role feel free to contact by email at. hjohn@barringtonjames.com
#J-18808-Ljbffr
Working with an exciting biotech company that has grown by over 75% in the last two years and is looking for a regulatory affair specialist to enhance their team. This company is focusing on pushing the limits of innovation and supply in global health! Key responsibilities
Supporting the preparation, review and correct submission of regulatory documentation for medical device/IVDs products ensuring compliance with all regulatory requirements including FDA, ISO 13485. Help to prepare PMA packages, including nonclinical, manufacturing, and clinical sections. Working on analytical performance test with product development teams to draft documentation Requirements
Bachelor’s degree in regulatory affairs, engineering and life sciences or a health or science related field is required. Professional experience
2+ years of regulatory affairs experience within the medical device or IVD industry. Experience interacting with FDA regulations and guidance (510k). If interested in this role feel free to contact by email at. hjohn@barringtonjames.com
#J-18808-Ljbffr