Global Regulatory Affairs Manager – Medical Devices

INSIGHTEC; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Insightec is a growing medical technology company transforming patient lives through incisionless surgery. We seek a Regulatory Affairs professional to lead clinical submissions and ensure ongoing regulatory compliance across markets.

The role requires a B.Sc. in a scientific/technical field and at least 6 years of hands-on experience with medical device regulatory submissions, including IDE/IND, ITA/CTA, and EU CTAs. Excellent communication and collaboration are essential.

Qualifications

• B.Sc. degree in scientific/technical discipline or engineering.
• Minimum 6 years of hands-on experience with medical devices regulatory submissions (IDE/IND, ITA/CTA, EU CTAs).
• Strong verbal and written communication skills; ability to work with cross-functional global teams.

Responsibilities

• Prepare and maintain clinical regulatory submissions for INSIGHTEC products in relevant markets.
• Review clinical documents for regulatory appropriateness and ensure scientific rigor in submissions.
• Serve as US Agent for Insightec and manage cross-functional regulatory activities.
• Support regulatory, clinical and post-market activities including license renewals and complaint reports.
• Collaborate with R&D, Clinical, Quality, and Marketing teams to ensure compliance and quality.

Skills

Regulatory submissions

Cross-functional teamwork

Regulatory compliance

Medical devices

Education

B.Sc. degree

Job description

Insightec is a growing medical technology company transforming patient lives through incisionless surgery. We seek a Regulatory Affairs professional to lead clinical submissions and ensure ongoing regulatory compliance across markets.

The role requires a B.Sc. in a scientific/technical field and at least 6 years of hands-on experience with medical device regulatory submissions, including IDE/IND, ITA/CTA, and EU CTAs. Excellent communication and collaboration are essential.