Regulatory Affairs Lead – Medical Devices & Compliance

The Metrix Company; Dubuque (IA); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Dental and vision insurance

Life insurance

Job summary

The Metrix Company, a leading manufacturer of single-use medical devices, seeks a Regulatory Affairs Specialist to collaborate with Engineering and Quality Assurance to maintain regulatory knowledge and ensure compliance across US and international markets.

You will lead internal audits, manage submissions and regulatory files, review labeling and promotional materials, and guide audits by FDA and Notified Bodies while coordinating CAPA and post-market surveillance.

Qualifications

• Bachelor's degree in a healthcare/biomedical field and 3+ years in regulatory affairs or quality for medical devices.
• Experience maintaining ISO 13485, FDA 21 CFR 820, and related regulatory programs.
• Strong analytical, problem-solving, and cross-functional leadership skills.

Responsibilities

• Maintain regulatory knowledge base on regulations, standards, and guidance documents.
• Lead internal and supplier audits; develop schedules and track CAPA closures.
• Prepare submissions (510(k) and other filings) and maintain regulatory files.
• Coordinate with FDA audits, Notified Bodies, and customer audits; provide post-inspection information.
• Review labeling, IFUs, batch records and promotional materials for compliance.

Skills

Regulatory affairs

Quality assurance

Medical devices

FDA regulations

Auditing

CAPA

Education

Bachelor of Science in Healthcare

Biomedical Science

Biology

Chemistry

Related field

Job description

The Metrix Company, a leading manufacturer of single-use medical devices, seeks a Regulatory Affairs Specialist to collaborate with Engineering and Quality Assurance to maintain regulatory knowledge and ensure compliance across US and international markets.

You will lead internal audits, manage submissions and regulatory files, review labeling and promotional materials, and guide audits by FDA and Notified Bodies while coordinating CAPA and post-market surveillance.