What are the responsibilities and job description for the Manager, Regulatory Affairs CDx position at Labcorp?
At Labcorp we have a passion in helping people live happy and healthy lives. Every day we provide vital information that helps our clients and patients understand their health. If you are passionate about helping people and have a drive for service, then Labcorp could be a great next career step!
Job Description:
- Provides regulatory support to CDx and device project teams for the diagnostic, covering all areas from CDx development through approval and launch
- Provides regulatory support and input to internal teams involved with IVD/CDx development planning to ensure that the IVD/CDx will meet health authority expectations
- Drafts relevant sections of device regulatory submissions, as appropriate
- Provides guidance to the teams on the regulatory requirements supporting CDx submissions to US FDA and other global health authorities and ensuring that all regulatory submissions are planned, communicated, and executed per regulatory and business requirements
- Participates in internal and joint project teams as a regulatory SME Participates in meetings with regulatory agencies in collaboration with diagnostic partners and/or internal teams
- Provide interpretation of applicable regulations, guidances, and standards to project teams and clients
- Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance
- Contributes to the development and revision of SOPs and standard plans/templates/guidelines to ensure adherence to applicable ethical requirements, regulations, and standards.
Education Required:
Bachelors in Life Science degree
Experience Required:
5 years minimum experience
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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