Senior Regulatory Specialist - Medical Device Submissions

Cypress HCM; Minneapolis (MN); Sur place; USD 80 000 - 120 000; Plein temps

Résumé du poste

A medical equipment company is seeking a Mid-Senior level Quality Assurance professional to assist with regulatory documentation and medical writing. The role involves reviewing engineering test reports, monitoring regulatory requirements, and ensuring compliance with FDA regulations. Ideal candidates will have at least 3 years of experience, strong writing skills, and proficiency in Microsoft Office Suite. This full-time position offers a competitive salary ranging from $80,000 to $120,000 annually, based in Minneapolis, Minnesota.

Qualifications

• Minimum of 3 years of scientific and/or regulatory experience.
• Strong experience writing and reviewing regulatory documentation.
• Excellent communication skills required.

Responsabilités

• Review engineering test reports and regulatory submissions.
• Approve documentation change requests.
• Monitor domestic and international medical device regulations.
• Ensure compliance with FDA submissions.

Connaissances

Scientific and regulatory experience

Technical documentation writing

Excellent verbal communication

Organizational skills

Attention to detail

Outils

Microsoft Office Suite

Description du poste

A medical equipment company is seeking a Mid-Senior level Quality Assurance professional to assist with regulatory documentation and medical writing. The role involves reviewing engineering test reports, monitoring regulatory requirements, and ensuring compliance with FDA regulations. Ideal candidates will have at least 3 years of experience, strong writing skills, and proficiency in Microsoft Office Suite. This full-time position offers a competitive salary ranging from $80,000 to $120,000 annually, based in Minneapolis, Minnesota.