Bachelor's degree or certificate in medical devices
2+ years experience in medical devices industry
Knowledge of regulatory guidelines for diagnostic products
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Danaher is seeking a Specialist in Commercial Regulatory Affairs to manage regulatory submissions and compliance for its diagnostic products. This fully remote position offers the opportunity to contribute to life-saving innovations in the life sciences field while being part of a collaborative and flexible work culture.
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Job Summary
This role involves leading pre-market and post-market regulatory activities for IVD devices including preparation and submission of technical documentation.
The position requires maintaining regulatory intelligence and compliance at local, regional, and global levels throughout the product lifecycle.
Danaher offers comprehensive benefit programs and flexible remote working arrangements for eligible roles.
Matching Summary
Match Score: 75
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Danaher is seeking a Specialist in Commercial Regulatory Affairs to manage regulatory submissions and compliance for its diagnostic products. This fully remote position offers the opportunity to contribute to life-saving innovations in the life sciences field while being part of a collaborative and flexible work culture.
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Skills & Requirements
Must-have
Bachelor's degree or certificate in medical devices
2+ years experience in medical devices industry
Knowledge of regulatory guidelines for diagnostic products
Ability to prioritize and multitask in fast-paced environment
Nice-to-have
Certified audit certificate for ISO13485 or ISO9001
Experience performing in-country IVD submissions in Southeast Asia
Support local audits and act as Quality Management Representative
Key Requirements
Bachelor's degree with 2+ years relevant experience
Certificate in medical devices with 2 years experience
3+ years experience in medical devices or related industry
Familiarity with regulations governing diagnostic product development