Quality Assurance and Regulatory Affairs Specialist
1 week ago
Job Title: Quality Assurance and Regulatory Affairs Associate
Job Summary:
We are seeking a highly motivated and detail-oriented Quality Assurance and Regulatory Affairs Associate to join our team at Standard BioTools. The successful candidate will be responsible for maintaining and ensuring that our company quality system meets requirements for medical devices and international directives.
Key Responsibilities:
- Maintain Technical Documentation files in compliance with international requirements.
- Oversee the company REACH and Safety Data Sheet program.
- Approval and release of Quality Records, Device History Records, Batch Records Master Labels and Device Master Records.
- Support and administration of risk assessment review process and implementation of changes to risk management process as needed.
- Liaison with domestic and international customers and vendors to ensure compliance with standards and execution of corrective actions.
- Development of controlled documents and procedures pertinent to Quality Assurance activities and functions.
- Assists with customer complaints/CAPA system.
- Supports new product development, risk analysis, and launch processes, and manage QA participation on new production development.
Requirements:
- Bachelor's degree required, life science / engineering.
- Regulatory Affairs / Quality Management RAC certificate is preferred.
- Experience with ISO 13485, ISO 9001, required.
- Knowledge of and experience with the following standards: IEC 60601-1, ISO 13485, ISO 14971, IEC 62366, IEC 62304, CE-IVDR and 21 CFR 820.
- Knowledge with REACH, RoHS, WEEE, CE mark, UKCA directives and Safety Data Sheet compliance.
- ASQ Certification preferred but not required (such as CQA, CQE, CMQ/OE).
- 1-2 years of industry experience preferred.
- ISO 13485 Internal Auditor certificate a plus.
- Salesforce Experience a plus.
- Basic knowledge of Excel.
- Fast learner, self-starter, accountable, reliable.
- Ability to successfully work in a dynamic environment.
- Able to work under pressure and tight timelines.
- Problem solving attitude.
- Cross-functional perspective and coordination.
About Us:
Standard BioTools is a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health. We are committed to providing an inclusive and barrier-free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA).
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