Regulatory Affairs Specialist

CorDx; Alpharetta (GA); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Comprehensive medical insurance

401(k) plan with company contributions

Flexible paid time off (PTO) policy

Job summary

A multi-national biotech company located in Alpharetta, Georgia is seeking a Regulatory Affairs Specialist to support the preparation and submission of regulatory documentation for medical devices. Candidates should have a Bachelor's degree and 2-3 years of regulatory affairs experience in the medical device or IVD industry. Strong organizational and communication skills are essential for ensuring compliance with FDA and international standards. This role includes benefits like comprehensive medical insurance and a 401(k) plan.

Qualifications

• 2-3 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.

Responsibilities

• Prepare, review, and coordinate the 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.
• Maintain documentation and records of all regulatory submissions and correspondence.

Skills

Solid understanding of FDA regulations and Guidance

Strong organizational skills

Excellent communication

Problem-solving skills

Ability to manage multiple projects

Education

Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field

Job description

About Us

CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-12, pregnancy, drug abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Position Summary

The Regulatory Affairs Specialist will support the preparation, review, and submission of regulatory documentation for medical device/IVDs products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position focus on submitted documents preparing, helping to secure timely product approvals and regulatory clearances.

Key Responsibilities

• Prepare, review, and coordinate the 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
• Working on analytical performance test withproduct development teams to draft documentation.
• Perform regulatory assessments for product changes and propose appropriate regulatory pathways
• Maintain documentation and records of all regulatory submissions and correspondence
• Support the preparation for regulatory agency meetings, audits, and inspections

Education

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required

Language

• English
• Mandarin Preferred

Professional Experience

• 2-3years 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

Skills & Competencies

• Solid understanding of FDA regulationsand Guidance. (510k, PMA, De novo)
• Strong organizational and project management skills with the ability to manage multiple projects and priorities
• Excellent communication, problem-solving, and attention to detail
• Ability to work collaboratively in cross-functional teams and manage document workflows

Benefits

• Comprehensive medical insurance.
• 401(k) plan with company contributions.
• Flexible paid time off (PTO) policy.