Global Device Regulatory Lead — Associate Director

Sanofi; Cambridge (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading pharmaceutical company is seeking an experienced Global Regulatory Affairs Device Lead to develop and execute innovative regulatory strategies for medical devices. The role requires 8+ years of relevant industry experience, strong regulatory expertise, and effective collaboration with cross-functional teams. The position offers a comprehensive rewards package and extensive health and wellbeing benefits.

Benefits

Health and wellbeing benefits

14 weeks’ gender-neutral parental leave

Qualifications

• 8+ years of relevant industry experience, including regulatory expertise.
• Familiarity with standard submission processes and regulatory requirements.
• Strong written and verbal communication skills; fluency in English.

Responsibilities

• Develop and execute medical device regulatory strategies.
• Lead global filing and lifecycle management for device submissions.
• Identify regulatory risks and propose risk mitigations.

Skills

Regulatory Expertise

Collaboration Skills

Strategic Thinking

Change Agent Leadership

Education

Bachelor's degree in a scientific or engineering discipline

Graduate degree preferred

Job description

A leading pharmaceutical company is seeking an experienced Global Regulatory Affairs Device Lead to develop and execute innovative regulatory strategies for medical devices. The role requires 8+ years of relevant industry experience, strong regulatory expertise, and effective collaboration with cross-functional teams. The position offers a comprehensive rewards package and extensive health and wellbeing benefits.