Cordx
Senior Regulatory Affairs Manager (Onsite)
Atlanta, Georgia, United States · Senior · Full-time
Sponsorship not specifiedDetected 450 days ago
Data ScienceProject ManagementNegotiationFDA RegulatoryMedical DevicesLeadershipCommunicationProblem SolvingRegulatory Affairs
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Lottery odds40
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About the role
- The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions.
- This individual will ensure compliance with all applicable regulations in the preparation of the submissions to FDA, provide regulatory guidance to cross-functional teams, and contribute to the successful approval and launch of innovative medical devices.
Responsibilities
- Prepare, review, and submit regulatory documents to FDA.
- Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
- Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines.
- Represent the company in meetings with regulatory agencies and external partners as needed.
- Strong leadership and project management skills, with the ability to manage multiple projects and priorities.
Nice to have
- Master's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field
- advanced degree preferred.
Skills
- In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations.
- Excellent communication, negotiation, and problem-solving skills.
- Detail-oriented with strong organizational skills.
- 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:
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.
- Minimum of 7-10 years of experience in regulatory affairs within the medical device industry.
- Skills & Competencies: In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations.
- 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.