Not specified; not specified; comprehensive compet...
Fully remote
Bachelor's degree with relevant experience
2+ years medical device industry experience
Regulatory submission preparation and management
Danaher UK is seeking a Specialist in Commercial Regulatory Affairs to prepare regulatory submissions and interact with health authorities for product approvals in the life sciences and diagnostics sectors. The role emphasizes a commitment to innovation, teamwork, and continuous improvement, all within a fully remote work environment
Job Summary
This role involves leading pre-market and post-market regulatory activities for IVD devices including technical documentation and renewals.
The position offers the opportunity to maintain regulatory intelligence and ensure adherence to applicable regulations throughout the product lifecycle.
Danaher provides a culture of belonging where unique viewpoints matter and offers comprehensive benefit programs contributing to life beyond the job.
Matching Summary
Match Score: 85
Danaher UK is seeking a Specialist in Commercial Regulatory Affairs to prepare regulatory submissions and interact with health authorities for product approvals in the life sciences and diagnostics sectors. The role emphasizes a commitment to innovation, teamwork, and continuous improvement, all within a fully remote work environment.
Salary
Not specified; Not specified; Comprehensive competitive benefit programs offered
Skills & Requirements
Must-have
Bachelor's degree with relevant experience
2+ years medical device industry experience
Regulatory submission preparation and management
IVD device regulatory activities knowledge
Quality management process oversight
Nice-to-have
Certified audit certificate ISO13485 or ISO9001
Experience performing in-country IVD submissions
Ability to perform local audits
Flexible and adaptable work style
Fast-paced environment capability
Key Requirements
Bachelor's degree required
2+ years relevant experience in medical devices
Familiarity with diagnostic product regulations
ISO13485 or ISO9001 certification (preferred)
Southeast Asia IVD submission authority (preferred)