Katalyst CRO
Overview
Regulatory Affairs Specialist-II
role at
Katalyst CRO Join to apply for the Regulatory Affairs Specialist-II role at Katalyst CRO. Responsibilities
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 Nominated Body reviewed EU Technical File preparation. 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. Lead, 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 510K submissions. Experience authoring FDA Q-submissions. Experience with Class II and Class III 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 labeling to ensure compliance with US and international regulatory requirements. Problem solving and communication skills are essential. Excellent technical writing skills. Ability to lead multiple projects from inception to completion. Statistics and database management proficiency.
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Regulatory Affairs Specialist-II
role at
Katalyst CRO Join to apply for the Regulatory Affairs Specialist-II role at Katalyst CRO. Responsibilities
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 Nominated Body reviewed EU Technical File preparation. 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. Lead, 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 510K submissions. Experience authoring FDA Q-submissions. Experience with Class II and Class III 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 labeling to ensure compliance with US and international regulatory requirements. Problem solving and communication skills are essential. Excellent technical writing skills. Ability to lead multiple projects from inception to completion. Statistics and database management proficiency.
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