Cordx
Regulatory Affairs Manager (Atlanta)
Atlanta, Georgia, United States · Full-time
Sponsorship not specifiedDetected 446 days ago
Data ScienceProduct ManagementProject ManagementFDA RegulatoryMedical DevicesCommunicationProblem SolvingRegulatory Affairs
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Lottery odds40
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About the role
- The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards.
- This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.
Responsibilities
- Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies.
- Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements.
- 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.
- Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory deliverables are met in a timely manner.
- Strong organizational and project management skills with the ability to manage multiple projects and priorities.
- Ability to work collaboratively in cross-functional teams and manage document workflows.
Requirements
- Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required.
Nice to have
- Working knowledge of 510(k) submissions and regulatory documentation processes.
- Experience interacting with FDA and other regulatory agencies preferred.
- Master's degree preferred.
Skills
- Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and medical device regulatory requirements.
- Excellent communication, problem-solving, and attention to detail.
- Highly competitive compensation package.
- Comprehensive medical, dental, and vision insurance.
- 401(k) plan with generous company contributions.
- Flexible paid time off (PTO) policy.
- Additional substantial benefits.
- Equal Opportunity Statement:
- Skills & Competencies: Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and medical device regulatory requirements.
Benefits
- Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health.
- 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.
- Education: Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required.
- Professional Experience: 5-7 years of regulatory affairs experience within the medical device or IVD industry.
- We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
Company info
- Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity.
Equal opportunity
- Statement: We are an equal opportunity employer committed to inclusion and diversity.
This listing is sourced directly from Cordx's careers page and normalized into a canonical job model.