Katalyst Healthcares and Life Sciences
Regulatory Affairs Specialist-II
Katalyst Healthcares and Life Sciences, Okemos, Michigan, United States, 48864
Responsibilities:
Regulatory Affairs Specialist II provides pre-market and post-market regulatory support to US FDA, Health Canada, EU, and other International Regulatory Licensing and Registration Agencies. Lead and Support US 510K Submissions. Lead and Support Health Canada Device License Applications. Lead and Support Self Certified and Notified Body Reviewed EU Technical File Preparation. Lead regulatory affairs departmental projects. Support International Device Licensing and Registrations. Support Product Development Teams for New Product Submission Requirements. Participate in and support internal and external Quality System Audits. Produce Technical Writing. Coordinate Departmental activities for International Device Licensing and Registrations. Leads, participate in, and support Internal and External Quality System Audits. Requirements:
Bachelor's degree or higher in biological science, or a related health field preferred. Experience with international product registrations. Experience authoring 5 10k submissions. Experience authoring FDA Q-submissions. Experience with Class Il and Class Ill Health Canada license applications. Experience with Class B and Class C IVDR submissions. Experience supporting ISO: 13485 and MDSAP audits. Experience reviewing and assessing design changes for regulatory impact. Experience working with R&D teams and providing input during the product development cycle. Experience reviewing and creating labelling to ensure compliance with US and International Regulatory Requirements. Problem solving and communication skills a must Excellent technical writing skills. Ability to lead multiple projects through inception through to completion. Statistics and database management proficiency.
Regulatory Affairs Specialist II provides pre-market and post-market regulatory support to US FDA, Health Canada, EU, and other International Regulatory Licensing and Registration Agencies. Lead and Support US 510K Submissions. Lead and Support Health Canada Device License Applications. Lead and Support Self Certified and Notified Body Reviewed EU Technical File Preparation. Lead regulatory affairs departmental projects. Support International Device Licensing and Registrations. Support Product Development Teams for New Product Submission Requirements. Participate in and support internal and external Quality System Audits. Produce Technical Writing. Coordinate Departmental activities for International Device Licensing and Registrations. Leads, participate in, and support Internal and External Quality System Audits. Requirements:
Bachelor's degree or higher in biological science, or a related health field preferred. Experience with international product registrations. Experience authoring 5 10k submissions. Experience authoring FDA Q-submissions. Experience with Class Il and Class Ill Health Canada license applications. Experience with Class B and Class C IVDR submissions. Experience supporting ISO: 13485 and MDSAP audits. Experience reviewing and assessing design changes for regulatory impact. Experience working with R&D teams and providing input during the product development cycle. Experience reviewing and creating labelling to ensure compliance with US and International Regulatory Requirements. Problem solving and communication skills a must Excellent technical writing skills. Ability to lead multiple projects through inception through to completion. Statistics and database management proficiency.