Director of Regulatory Affairs and Design Assurance - Remote

Overview

The Director of Regulatory Affairs and Design Assurance will lead the development and execution of regulatory strategies, ensuring compliance with relevant regulations and overseeing the regulatory submission process for medical devices and IVDs.

In Short

• Set vision and direction for regulatory affairs.
• Motivate and inspire the regulatory affairs team.
• Plan and organize team projects effectively.
• Own the development and execution of regulatory strategy.
• Develop systems for efficient global regulatory approvals.
• Support execution of regulatory affairs deliverables.
• Act as the person responsible for regulatory compliance.
• Ensure compliance with labeling and documentation standards.
• Maintain up-to-date knowledge of regulations affecting products.
• Lead verification and validation studies.

Requirements

• Bachelor’s degree in science or related field.
• 5+ years of managerial experience in a regulated environment.
• Experience with regulatory submissions for medical devices or IVDs.
• Familiarity with FDA, ISO 13485, and other regulatory requirements.
• Strong technical writing and communication skills.
• Highly organized with attention to detail.
• Able to work in a fast-paced environment.
• Ability to work independently and in a team.
• Proficient in improving and simplifying processes.

Benefits

• Equal Opportunity Employment.
• Comprehensive background check policy.