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Senior Specialist in Regulatory Affairs for Core and NGS Technologies
2 months ago
About Danaher Corporation: Danaher Corporation is a global leader in the life sciences and diagnostics sectors, committed to innovation and excellence in our products and services.
Position Overview: We are seeking a Senior Specialist in Regulatory Affairs for Core and NGS Technologies. This role is integral to our Quality Assurance and Regulatory Affairs team, focusing on the regulatory landscape for in vitro diagnostics.
Key Responsibilities:
- Support a dedicated team in managing global submission processes, maintaining regulatory approvals, and developing comprehensive regulatory strategies.
- Provide mentorship and guidance to junior regulatory professionals, fostering their growth and expertise.
- Author and review essential regulatory documentation for market entry, ensuring compliance with global standards.
- Collaborate cross-functionally to enhance regulatory processes, provide training, and contribute to new product development initiatives.
- Assist in internal and external audits, ensuring adherence to regulatory requirements.
- Evaluate marketing materials for regulatory accuracy and compliance, offering support and training to the marketing department.
Qualifications:
- A minimum of a bachelor’s degree in a relevant technical field such as chemistry, biochemistry, or biology.
- At least 4 years of experience in global regulatory affairs related to in vitro diagnostics.
- Strong knowledge of international IVD regulations, quality standards, and product development processes.
- Experience in Quality Management Systems (QMS) and effective cross-functional communication.
Preferred Qualifications:
- Experience with IVD software and the assay development process.
Work Environment: This position offers the flexibility of remote work arrangements, allowing you to contribute from your home environment.
Compensation and Benefits: We offer a competitive salary range and a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and a 401(k) plan.
Diversity and Inclusion: Danaher Corporation is an equal opportunity employer, valuing diversity and inclusivity in our workforce.
