Regulatory Affairs Specialist IV - Remote

Overview

The Regulatory Affairs Specialist IV position ensures compliance with global medical device regulations throughout the product lifecycle (Class 2 medical devices, electromechanical devices, patient contact devices, Software as a medical device, as well as digital health related devices).

In Short

• Develop and implement global regulatory strategies.
• Prepare, submit, and maintain product registrations and approvals.
• Lead 510(k) submissions for FDA.
• Interface with regulatory agencies and respond to inquiries.
• Provide regulatory input for product labeling and promotional materials.
• Monitor new regulatory requirements and ensure compliance.
• Support product development teams with regulatory guidance.
• Participate in audits and inspections.
• Support continuous improvement activities within QMS.
• Assist with other duties as assigned.

Requirements

• Bachelor of Science degree.
• At least 8 years of regulatory affairs experience in the medical device industry.
• Experience leading successful 510(k) clearances and CE marking.
• Current experience with international regulatory registrations.
• Knowledge of digital health and Software as a Medical Device.
• Strong understanding of medical device product life cycle.
• In-depth knowledge of ISO 13485, FDA regulations, and EU MDR.
• Proficiency in database systems and advanced Microsoft Excel skills.
• Strong verbal and written communication skills.
• Strong analytical and critical thinking skills.

Benefits

• Competitive base salary.
• Annual performance bonus incentive plan.
• Health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Generous paid leaves including vacation and sick leave.
• Paid volunteer time.
• Strong culture of excellence.