Senior Regulatory Affairs Manager (Onsite)
a day ago
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OnsiteFull-timeSenior
Summary
CorDx is seeking a Senior Regulatory Affairs Manager to join their team onsite in Atlanta or San Diego. The role involves leading and managing regulatory submissions for medical device products, ensuring compliance with FDA regulations.
About the Role
As a Senior Regulatory Affairs Manager, you will be responsible for preparing, reviewing, and submitting regulatory documents to the FDA, managing the regulatory submission process, and providing regulatory guidance to cross-functional teams. You will ensure compliance with applicable regulations, stay updated on regulatory changes, and represent the company in meetings with regulatory agencies.
About You
Required:
- Master's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
- Minimum of 7-10 years of experience in regulatory affairs within the medical device industry.
- Proven track record of leading and successfully obtaining 510(k) and De Novo clearances/approvals.
- Experience in interacting with FDA and other regulatory agencies.
Preferred:
- Advanced degree in a relevant field.
- In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations.
Benefits
- 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.
CorDx
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 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 disease such as COVID-19, pregnancy, drugs of 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. #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Atlanta, GA