Job Title: Director Regulatory Affairs and Quality (Medical Device/Diagnostics)
Location: Cambridge, MA / Accepting Remote EST candidates
ABOUT THE ROLE:
I am currently working with a Rare Disease biotechnology company focused on transforming clinical, genetic, and biochemical data into medical solutions for patients. oversee the international regulatory systems, implementations, development, and auditing, while supporting all FDA interactions. If you are looking to play a major role in a secured, growing biotechnology company in the Biotech Hub of Boston, withhold medical device/ diagnostics experience, and have Global Regulatory and Quality knowledge? Now is the time to apply!
RESPONSIBILITIES
In this role you will be responsible for:
- Developing and executing regulatory plans for all assigned programs
- Supporting regulatory and compliance guidance from business development and to customers
- Support all Regulatory agency interactions- worldwide health authorities; FDA/EMA
- Being involved directly and indirectly in the diagnostic and product development processes
- Schedule and execute all laboratory/ documentation audits
- Working cross functionally within Quality; Creating SOP's and structuring Quality documents
QUALIFICATIONS
In this role you must have:
- 7-10 years relevant Global Regulatory experience
- Medical Device/Diagnostics experience
- Strong CTD/ eCTD Format for Regulatory filing
- Previous laboratory operation for biotechnology or Medical Diagnostic companies
- Previous Global Health Authority experience
- GLP, GMP, ISO, CAP, CLIA, FDA requirements are necessary
