Senior Regulatory Affairs Lead — Medical Devices

AtriCure, Inc.; Minnetonka (MN); On-site; USD 106,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental

401K match

Parental Leave

Volunteer Time Off

Pet Insurance

On-site fitness center & cafeteria

Job summary

AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate documents to obtain and maintain marketing privileges worldwide.

You will prepare submissions, including US 510(k) and PMA supplements, and handle EU, Canada, Australia, and other international filings. The role serves as regulatory lead on development projects, supports post-market changes, and collaborates with FDA, EU Notified Body, Health Canada and others to facilitate timely reviews.

Qualifications

• Bachelor's degree required or equivalent combination of education, training and experience.
• Minimum 4 years of regulatory affairs experience for medical devices.
• Knowledge of U.S. and/or European/international regulations and standards.
• Experience preparing regulatory submissions and interacting with FDA or other agencies.
• Strong technical writing skills; able to work in teams and communicate clearly.

Responsibilities

• Prepare regulatory strategies for new development and sustaining projects.
• Prepare US submissions including 510(k) and PMA; draft 510(k) letters.
• Prepare EU, Canada, Australia, Brazil, Japan submissions as needed.
• Serve as regulatory lead on new product development projects and changes.
• Support risk management activities and clinical evaluation.
• Liaise with FDA, EU Notified Body, Health Canada and others for approvals.
• Collaborate with regional regulatory staff to assess global impact of changes.
• Assist in development/maintenance of regulatory operations and documentation.
• Assist inspections and audits by regulatory authorities.
• Monitor regulatory environment changes and apply to change control.

Skills

Regulatory submissions

FDA interactions

Technical writing

Cross-functional collaboration

Regulatory knowledge

Project management

Microsoft Office

Education

Bachelor's degree

4-year technical/science degree

Tools

Microsoft Office

Job description

AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate documents to obtain and maintain marketing privileges worldwide.

You will prepare submissions, including US 510(k) and PMA supplements, and handle EU, Canada, Australia, and other international filings. The role serves as regulatory lead on development projects, supports post-market changes, and collaborates with FDA, EU Notified Body, Health Canada and others to facilitate timely reviews.