Senior Global Regulatory Strategist - IVD (Remote)

Danaher Corporation; United States; À distance; USD 110 000 - 135 000; Plein temps

Avantages offerts par ce poste

Remote work option

Résumé du poste

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Principal Regulatory Affairs Specialist to develop and execute global regulatory strategies for IVD medical devices and software, and to mentor entry-level staff.

You will author regulatory submissions, lead registrations, assess regulatory risk, and collaborate with cross-functional teams to ensure compliance with FDA, EU IVDR, ISO 13485, and 21 CFR Part 820 standards.

Qualifications

• Bachelor's degree in chemistry, biology, or related field.
• 7+ years in regulated environments; 4+ years global regulatory in IVD.
• Experience with FDA and EU IVD regulations; PMA/De Novo/510(k) submissions.

Responsabilités

• Author and lead regulatory submissions and registrations to obtain global approvals.
• Provide guidance on regulatory/quality documentation for product development.
• Assess regulatory risks and ensure compliance with standards and SOPs.

Connaissances

Regulatory submissions

Global regulatory

FDA/IVD regs

Design Control

Risk Management

ISO 13485/IVDR

Formation

Bachelor's degree in technical field

Description du poste

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Principal Regulatory Affairs Specialist to develop and execute global regulatory strategies for IVD medical devices and software, and to mentor entry-level staff.

You will author regulatory submissions, lead registrations, assess regulatory risk, and collaborate with cross-functional teams to ensure compliance with FDA, EU IVDR, ISO 13485, and 21 CFR Part 820 standards.