Regulatory Affairs Manager

1w1 week ago

CorDx

Atlanta, US · Full-time · $115,000 – $155,000

About this role

CorDx is a multi-national biotech organization pushing innovation in global health with over 2,100 employees serving millions in 100+ countries. It delivers rapid testing and point-of-care solutions for infectious diseases, pregnancy, drugs of abuse, and biomarkers. The Regulatory Affairs Manager prepares, reviews, and submits regulatory documentation for medical devices, ensuring FDA, ISO 13485, and global compliance.

This role coordinates 510(k) submissions, technical files, and other filings to agencies while providing guidance on regulations to product teams. Daily tasks include assessing product changes, proposing pathways, and maintaining submission records. The position supports agency meetings, audits, and inspections for timely approvals.

Collaboration occurs with cross-functional teams in R&D, Quality, and Operations to meet regulatory deliverables. The onsite Atlanta environment integrates regulatory input across the product lifecycle. This fosters efficient processes in a cutting-edge firm using AI and data science.

Professionals stay current on regulatory changes, assessing impacts on products and processes. The role drives product clearances and builds expertise in medical device regulations. Opportunities arise in a dynamic biotech advancing healthcare diagnostics worldwide.

Requirements

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required
Master’s degree preferred
5–7 years of regulatory affairs experience within the medical device or IVD industry
Working knowledge of 510(k) submissions and regulatory documentation processes
Experience interacting with FDA and other regulatory agencies preferred
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and medical device regulatory requirements
Strong organizational and project management skills with ability to manage multiple projects and priorities
Excellent communication, problem-solving, and attention to detail

Responsibilities

Prepare, review, and coordinate submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies
Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards
Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements
Stay current on changes in regulatory requirements and assist in assessing impact on company processes and products
Perform regulatory assessments for product changes and propose appropriate regulatory pathways
Maintain documentation and records of all regulatory submissions and correspondence
Support preparation for regulatory agency meetings, audits, and inspections
Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory deliverables are met in a timely manner