Global Regulatory Lead - Medical Devices & Compliance

Tecomet; Warsaw (AL); On-site; USD 90,000 - 120,000; Full time

Job summary

Tecomet seeks a Sr Regulatory Affairs Specialist to manage regulatory submissions, annual reports, registrations and listings, ensuring compliance with FDA and international regulations. You will guide teams and communicate regulatory requirements clearly across the organization to meet domestic and global demands.

The role requires strong knowledge of medical device regulations, 4+ years of experience, and collaboration with multiple departments to maintain quality management and regulatory

Qualifications

• Minimum four years of experience in a quality and regulatory related field.
• Working knowledge of FDA, international and national medical device regulations.
• Bachelor's degree preferred in a relevant field.

Responsibilities

• Field complaint investigations and reporting.
• Perform regulatory reviews of design files for release.
• Collaborate with departments to address compliance issues.
• Provide training and support on compliance matters.
• Liaise with regulatory bodies and maintain FDA MDL listings.
• Participate in ISO audits and Technical File Reviews.

Skills

Regulatory interpretation

Communication

Analytical thinking

Project management

Team collaboration/leadership

Education

Bachelor of Science Degree

Tools

MS Word

MS Excel

PowerPoint

Job description

Tecomet seeks a Sr Regulatory Affairs Specialist to manage regulatory submissions, annual reports, registrations and listings, ensuring compliance with FDA and international regulations. You will guide teams and communicate regulatory requirements clearly across the organization to meet domestic and global demands.

The role requires strong knowledge of medical device regulations, 4+ years of experience, and collaboration with multiple departments to maintain quality management and regulatory