DescriptionPOSITION PURPOSE: The objective of the Regulatory Affairs Manager is to obtain and maintain approval for meeting FDA regulations for all Biomed manufactured and acquired products for the US and Canadian markets, including the registration and compliance for Biomed Diagnostics worldwide while supervising the Quality Assurance department.
REPRESENTATIVE DUTIES AND RESPONSIBLITIES: Core duties and responsibilities include the following.
Other duties may be assigned.
- Assist research in fields related to current and developing technical applications, new product development, and relevant journal reviews for the purpose of in-house database building.
- Ensure compliance with BioMed Quality System requirements and in-vitro diagnostic regulatory compliance to ISO 13485, FDA (21 CFR Part 820, and related REGULATIONS ), and USDA REGULATIONS AND FOR all appropriate international MARKETS AND regulations.
- Prepares submissions for 510K.
- Support QA department to ensure the Quality System is and will continue to be ready for ISO/FDA quality system audits.
- Maintain the third- party approval of technical files required for CE marking and Design History Files (DHFs) and Device Master Records (DMRs) for FDA compliance as appropriate.
- Support with UDI bar coding compliance.
- All other duties may be assigned
- Attendance at all employee meetings
- The Quality Assurance department will directly report to this position.
ESSENTIAL FUNCTIONS, REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
- Experience with seeing through in vitro Microbiology product development, FDA 510k clearance, and product launch
- 3-5 years of experience managing ISO registered Quality Management System.
- Experience managing and responding to FDA quality audits.
- Experience managing compliance with ISO and related standards for EU compliance including Risk Management, Usability, Safety, Labeling, and others.
- 25% travel required, primarily to conduct supplier quality audits at critical suppliers
- Proficient in PC applications including Microsoft Windows, Outlook, Word, Excel, Access, Project, and PowerPoint.
Job RequirementsEducation Required: Associate
Experience Required: 3-5 Years
Last updated on 06/24/2021
25.00 - 30.00
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