Global Head of Regulatory Affairs (Medical Devices)

Pulpdent-Corporation; Watertown (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Pulpdent Corporation in Watertown, MA, seeks a Head of Regulatory Affairs to guide global regulatory strategy across R&D, manufacturing, and marketing. Lead a high-performing team, manage FDA submissions, and ensure compliance with EU MDR and ISO 13485.

This on-site role partners with R&D, quality, and operations to enable safe, compliant products worldwide. The ideal candidate has 10+ years in medical devices regulatory affairs, a strong leadership track record, and deep knowledge of

Qualifications

• Bachelor's degree in a scientific, engineering, or healthcare-related field; advanced degree preferred.
• 10+ years of progressive regulatory affairs experience in medical devices; dental materials preferred.
• Demonstrated leadership for regulatory teams and cross-functional initiatives.
• Deep knowledge of FDA medical device regulations and international frameworks; EU MDR preferred.

Responsibilities

• Define, lead, and optimize global regulatory strategies aligned with business goals.
• Oversee regulatory submissions and registrations with FDA and international bodies.
• Guide product development with regulatory input across lifecycle stages.
• Collaborate with QA and production to ensure regulatory and QMS alignment.
• Cultivate a culture of compliance and effective stakeholder communication.

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

FDA regulations

Education

Bachelor's degree in science/engineering/healthcare

Advanced degree preferred

Tools

eQMS

ISO 13485 knowledge

Job description

Pulpdent Corporation in Watertown, MA, seeks a Head of Regulatory Affairs to guide global regulatory strategy across R&D, manufacturing, and marketing. Lead a high-performing team, manage FDA submissions, and ensure compliance with EU MDR and ISO 13485.

This on-site role partners with R&D, quality, and operations to enable safe, compliant products worldwide. The ideal candidate has 10+ years in medical devices regulatory affairs, a strong leadership track record, and deep knowledge of