Regulatory Affairs Manager-Medical Devices

📋 Description

• Develop and implement global regulatory strategies that support medical device product development
• Provide regulatory leadership and guidance throughout all stages of product design, development
• Advise executive leadership on regulatory risks, business opportunities, emerging requirements, and
• Lead, mentor, and develop Regulatory Affairs team members, fostering technical expertise and
• Oversee the preparation, review, submission, and ongoing maintenance of regulatory filings and
• Ensure timely maintenance and renewal of product registrations, licenses, and approvals in all

🎯 Requirements

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs
• Master's degree in a relevant field is preferred.
• At least 7–10 years of professional experience in medical device regulatory affairs.
• Minimum of 3 years of leadership, supervisory, or project management experience.
• Demonstrated experience preparing and managing FDA regulatory submissions, international
• Strong knowledge of regulatory frameworks and requirements across the FDA, European Medical Device

🎁 Benefits

• Annual salary: $120,000–$140,000.
• Remote work arrangement, with opportunities for hybrid work and occasional onsite collaboration.
• Flexible work schedule.
• Health and dental insurance options.
• 401(k) retirement plan with employer matching.
• Employee Stock Ownership Plan (ESOP).