Global Regulatory Affairs Leader — Submissions & Strategy

Radiometer; Vista (CA); In loco; USD 155.000 - 165.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus eligibility

Comprehensive benefits package

401(k)

Descrizione del lavoro

Leica Biosystems, a Danaher company, seeks a Regulatory Affairs leader to drive global submissions and regulatory strategies for high‑risk diagnostic products. You will collaborate across Clinical Affairs, QA, R&D and Program Management to align plans, budgets, and timelines, while engaging regulators to secure approvals.

The role requires 5+ years in regulatory affairs for diagnostics, with FDA/EU IVDR experience and strong cross‑functional leadership. Travel ~15% is expected.

Competenze

• Bachelor’s, Master’s, or PhD in a scientific or engineering discipline.
• In‑depth working knowledge of FDA and EU regulatory requirements for IVD devices.
• 5+ years of progressive experience in regulatory affairs for diagnostic products (incl. 510(k)).
• Experience supporting clinical trials is a plus; global submissions expertise required.

Mansioni

• Lead a team responsible for global regulatory submissions (510(k), EU IVDR Technical Files, STED) by defining requirements and timelines.
• Collaborate with Clinical Affairs, QA, R&D and others to define regulatory strategies for technologies.
• Provide regulatory input for program planning, budgets, and timelines; align with partners on study designs.
• Engage with global regulatory agencies to achieve product clearance/approval and monitor evolving rules.

Conoscenze

Regulatory leadership

Global submissions

FDA/EU IVDR

Cross-functional collaboration

Regulatory strategy

Negotiation with regulators

Project planning

Formazione

Bachelor/Master/PhD in science or engineering

Descrizione del lavoro

Leica Biosystems, a Danaher company, seeks a Regulatory Affairs leader to drive global submissions and regulatory strategies for high‑risk diagnostic products. You will collaborate across Clinical Affairs, QA, R&D and Program Management to align plans, budgets, and timelines, while engaging regulators to secure approvals.

The role requires 5+ years in regulatory affairs for diagnostics, with FDA/EU IVDR experience and strong cross‑functional leadership. Travel ~15% is expected.