Sr Manager Regulatory Affairs

As Sr Manager Regulatory Affairs, you will lead the development and implementation of regulatory strategies for medical devices. You will work closely with cross-functional teams to ensure compliance with FDA regulations and quality systems. This role requires a strong understanding of regulatory affairs, medical devices, and quality systems. You will be responsible for developing and maintaining regulatory documents, managing regulatory submissions, and providing regulatory guidance to cross-functional teams.

Key Responsibilities

• Develop and implement regulatory strategies for medical devices.
• Manage regulatory submissions, including 510(k) and PMA applications.
• Provide regulatory guidance to cross-functional teams, including R&D, Manufacturing, and Quality.
• Develop and maintain regulatory documents, including technical files and regulatory reports.
• Collaborate with cross-functional teams to ensure compliance with FDA regulations and quality systems.

Requirements

• 10+ years of experience in regulatory affairs, with a focus on medical devices.
• Strong understanding of FDA regulations, including 21 CFR 820 and 21 CFR 803.
• Experience with quality systems, including ISO 13485 and ISO 9001.
• Excellent communication and project management skills.
• Ability to work in a fast-paced environment and prioritize multiple tasks.