Senior Regulatory Affairs Lead – Global Medical Devices

Regulatory Jobs; Mason (OH); On-site; USD 106,000 - 129,000; Full time

Job summary

AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate documents to obtain and maintain marketing privileges worldwide, including US 510(k), PMAs, and international submissions to support business growth.

The role will serve as regulatory representative on new product development projects, provide regulatory supervision on post-market changes, and coordinate with FDA, EU Notified Body, Health Canada and other agencies to ensure timely and favorable reviews.

Qualifications

• Bachelor’s degree required or equivalent experience in regulatory affairs.
• Minimum 4 years regulatory affairs experience for medical devices.
• Knowledge of US/EU/International regulations and standards.
• Experience preparing regulatory submissions and interacting with FDA or other agencies.

Responsibilities

• Prepare regulatory strategies for new products and sustaining projects.
• Prepare US submissions including 510(k), original PMAs and PMA supplements.
• Prepare EU, Canada, Australia, Brazil, Japan and other international submissions.
• Serve as regulatory lead on new product development and post-market changes.

Skills

Regulatory affairs

Regulatory strategy

Education

Bachelor’s degree

Job description

AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate documents to obtain and maintain marketing privileges worldwide, including US 510(k), PMAs, and international submissions to support business growth.

The role will serve as regulatory representative on new product development projects, provide regulatory supervision on post-market changes, and coordinate with FDA, EU Notified Body, Health Canada and other agencies to ensure timely and favorable reviews.