Senior Regulatory Affairs Lead – Medical Devices

Tecomet Inc.; Warsaw (IN); Sur place; USD 110 000 - 140 000; Plein temps

Résumé du poste

Tecomet Inc. seeks a Senior Regulatory Affairs Specialist to drive regulatory submissions, listings, and annual reports for medical devices across domestic and international markets.

You will lead audits, ensure QMS compliance, prepare Declarations of Conformities, and guide management on regulatory risks while coordinating with cross-functional teams to maintain product compliance and market access. The ideal candidate has four+ years in regulatory affairs, solid FDA/ISO knowledge, and strong

Qualifications

• Four+ years of regulatory experience in medical devices or equivalent field.
• Experience with FDA, ISO, and regulatory submissions.
• Strong knowledge of QMS and compliance requirements.

Responsabilités

• Field complaint investigations and reporting
• Regulatory reviews of product and design files for release
• Collaborate with departments to address compliance issues
• Provide training on compliance matters to staff
• Act as liaison with regulatory bodies
• Maintain FDA listings and regulatory submissions
• Participate in ISO audits and technical file reviews
• Annual review of Tecomet products (PMS)
• Prepare and issue Declarations of Conformities

Connaissances

Regulatory affairs

FDA regulations

Quality systems

Medical devices

Communication skills

Formation

Bachelor's degree

Outils

MS Office

Document control software

Description du poste

Tecomet Inc. seeks a Senior Regulatory Affairs Specialist to drive regulatory submissions, listings, and annual reports for medical devices across domestic and international markets.

You will lead audits, ensure QMS compliance, prepare Declarations of Conformities, and guide management on regulatory risks while coordinating with cross-functional teams to maintain product compliance and market access. The ideal candidate has four+ years in regulatory affairs, solid FDA/ISO knowledge, and strong