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Regulatory Assurance Specialist
2 months ago
Enhance Quality and Compliance in a Dynamic Environment
We are seeking a highly motivated Regulatory Assurance Specialist to join our team at Standard BioTools. This exciting opportunity will enable you to leverage your expertise in quality management and regulatory affairs to drive business growth while ensuring compliance with industry standards.
About the Role
The successful candidate will be responsible for maintaining and ensuring that our company's quality system meets requirements for medical devices, as outlined in international directives. This includes ensuring that products and their labeling meet all relevant regulatory requirements such as REACH, RoHS, WEEE, CE, etc.
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
To be successful in this role, you will need:
- Bachelor's degree in life science or engineering required
- Regulatory Affairs / Quality Management RAC certificate 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.
What We Offer
We offer a competitive salary of $80,000 - $110,000 per annum, depending on experience, and a range of benefits including professional development opportunities, a comprehensive health insurance package, and a generous retirement plan.
How to Apply
Please submit your application, including your resume and cover letter, through our website. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
