What are the responsibilities and job description for the Regulatory Affairs Specialist-II position at Katalyst CRO?
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.
- 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.
