Regulatory Affairs Specialist - Cardiac Surgery - Remote

Overview

The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions, and obtaining and maintaining approval for products in the cardiac surgery sector.

In Short

• Lead regulatory strategies for cardiac surgery products.
• Prepare submissions for FDA and global regulatory agencies.
• Collaborate with engineers and regulatory colleagues.
• Support marketed products and assess device changes.
• Maintain proficiency in worldwide regulatory requirements.
• Establish relationships with regulatory agencies.
• Assist in negotiations with the FDA.
• Participate in audits and post-market surveillance activities.
• Contribute to product development programs.
• Perform other related tasks as assigned.

Requirements

• Bachelor’s degree required.
• Minimum of 2 years in regulatory affairs for medical devices.
• Experience with Class II/III medical devices preferred.
• Knowledge of FDA and global regulatory requirements.
• Effective negotiation and communication skills.
• Strong organizational and time management skills.
• Detail-oriented and respectful team member.

Benefits

• Competitive salary and flexible benefits package.
• Health, dental, and vision insurance.
• 401(k) plan with employer contribution.
• Paid time off and holidays.
• Tuition assistance and reimbursement.
• Employee stock purchase plan.
• Short-term and long-term disability leave.