Regulatory Affairs Specialist II

Position Summary:

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work related to helping customers with their pandemic response measures and testing strategies. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

This role supports the new Rapid Diagnostics Solutions (RDS) business unit in San Diego, California, part of the group of diagnostics businesses at Thermo Fisher Scientific. We are focused on increasing access to affordable innovations in diagnostic testing and enabling data-driven decisions. What we do matters because our work has a direct impact on people’s lives, and we take that responsibility seriously.

The Regulatory Specialist will support Quality Management Systems and Regulatory Affairs areas. The role will provide QA/RA expertise to the Mesa Biotech, part of Thermo Fisher Scientific organization by performing a diverse set of responsibilities to develop, implement and maintain, documentation compliance for the quality systems

• Works with Regulatory and Clinical to support areas such as Submissions, Technical Files, and CE Mark
• Performs QA Review/Approval for Quality System documentation including Batch Record lot release, CAPA, NCRs, etc.
• Maintain, and report to senior management, the Quality Metrics.
• Provide training, guidance and coaching for GMP/GDP/Quality Systems, and Regulatory actions.
• Works collaboratively with Senior Management and other departmental functions such as Operations, R&D, Clinical, to resolve issues associated with Document Control, Quality Assurance, and Regulatory.
• Ensures regulatory compliance with established company and departmental policies and procedures, objectives, quality systems, regulations, safety and environmental standards.
• Other duties as assigned; as emerging growth company it may be required to assist in other areas other than the area of specialty.

Qualification and Requirements:

• Undergraduate degree preferred and/or a minimum of 5 years detailed oriented work experience in a regulated environment required.
• Strong knowledge of ISO 13485 and the FDA QSR’s as well as the point-of-care, in-vitro diagnostic (IVD). Knowledge of other country directives and regulations is highly preferred.
• Experience in supporting FDA, Competent Authority, and Notified Body Audits.
• Must possess excellent written and verbal communication skills.
• Intermediate level skill in Microsoft Word, Excel, Outlook and other office software programs. Knowledge of SolidWorks is a plus.
• Experience with Electronic Quality Management Systems, and electronic signature process compliant to FDA’s Part 11 for electronic records.