Regulatory Affairs Lead – Medical Devices & Compliance

Tecomet, Inc; Warsaw (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Tecomet, Inc. in Warsaw, IN seeks a Sr. Regulatory Affairs Specialist to lead regulatory submissions, maintain listings, and ensure compliance with FDA, ISO, and international standards.

You will coordinate audits, train staff, and liaise with regulatory bodies while ensuring product documentation and Declarations of Conformity are up to date across domestic and global markets. Ideal candidates have a BS in a scientific field, 4+ years in regulatory/QMS roles, and strong communication skills to

Qualifications

• Experience with government and international regulations for medical devices (FDA, MDD, ISO).
• Minimum four years in quality and regulatory fields or equivalent.

Responsibilities

• Field complaint investigations and reporting
• Perform regulatory reviews of Tecomet standard product and customer co-development design files to approve for release
• Collaborate with other departments to address compliance issues
• Provide training and support to staff on compliance matters
• Act as a liaison between the company and regulatory bodies
• Stay updated with changes in regulatory landscape and industry standards
• Advise senior management on compliance risks and mitigation strategies
• Maintain current knowledge of relevant regulations
• Annual review of all Tecomet products (PMS)
• Maintain FDA MDL listings/submissions for Tecomet and Customer products
• Create and submit Certificates to Foreign Government for Tecomet products
• Conduct First and Second Party Audits to Regulatory Standards
• Effectively document clear and concise audit reports and findings

Skills

Regulatory affairs

FDA regulations

Quality systems

Cross-functional collaboration

Education

Bachelor's degree in science

Tools

MS Word

Excel

PowerPoint

Job description

Tecomet, Inc. in Warsaw, IN seeks a Sr. Regulatory Affairs Specialist to lead regulatory submissions, maintain listings, and ensure compliance with FDA, ISO, and international standards.

You will coordinate audits, train staff, and liaise with regulatory bodies while ensuring product documentation and Declarations of Conformity are up to date across domestic and global markets. Ideal candidates have a BS in a scientific field, 4+ years in regulatory/QMS roles, and strong communication skills to