Regulatory Specialist
6 days ago
Who is 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.
Job Type:
Full time
Job Title:
Regulatory Specialist - IVD and 510(k)
Location:
Onsite - San Diego Office
Salary range:
$ 60,000 to $100,000
Department:
Regulatory Affairs
Responsibilities
- Manage all aspects of regulatory submission processes, including documentation, timelines, and communication with regulatory bodies, as needed.
- Conduct regulatory risk assessments and develop mitigation strategies for IVD products.
- Stay updated with regulatory changes and ensure all IVD products comply with current regulations.
- Liaise with internal departments (R&D, Quality, Manufacturing) to gather necessary documentation and data for regulatory submissions.
- Provide regulatory guidance on product development projects to ensure compliance from concept to commercialization.
- Review and provide input on product labeling, promotional materials, and change controls to ensure regulatory compliance.
- Assist in the development and implementation of regulatory strategies and update stakeholders on regulatory developments affecting the company's products.
Requirements:
- Bachelor's degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field.
- Minimum of 5 years of experience in relevant industry with min or 3 year hands on experience in 510(k) preparations and submissions.
- Strong understanding of FDA regulations, guidance documents, and processes related to IVD products.
- Experience in interacting with regulatory agencies, particularly the FDA.
- Excellent analytical, organizational, and communication skills.
- Detailoriented with the ability to manage multiple projects simultaneously.
Preferred Skills
RAC certification or similar.
Benefits
- Health Care Plan (Medical)
- 401K
- Paid Time Off and Paid Sick Leave
- Training & Development
We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.
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