- Are you looking for an opportunity where you will have the chance to implement and manage the quality and regulatory functions of a growing, award winning company?
- Do you get excited at the thought of reporting into the Founder, Chairman and CEO who is a renowned MIT and Harvard trained Physician and Physicist?
- Can you imagine yourself at a Cambridge, MA company that is on the cusp of rewriting the rules of personalized medicine, mobile diagnostics, and healthcare delivery?
Nanobiosym is seeking a Director of Quality Assurance and Regulatory Affairs who will have the opportunity to manage and ensure compliance and adherence of product specification and release testing, as well as provide quality assurance oversight supporting the commercialization of its pipeline of products. Integral to this activity will also be conformance with FDA Regulations (21 CFR 820), ISO 13485, ISO 14971, and cGMP manufacturing as it relates to IVD diagnostics.
A Typical Day:
- Initiate and refine regulatory strategy and mission to support filings and administration
- Develop QBD Quality By Design Plan as it applies to diagnostic product development.
- Provide Quality Assurance and Regulatory Affairs leadership supporting molecular IVD platform products.
- Supervise the Quality Assurance and Regulatory Affairs functional teams and third party contractors
- Monitor, implement, and improve overall quality and regulatory functionality, including QMS (system) assessment & vendor assisted implementation, document control, risk mitigation, raw material qualification, Quality Control testing, CAPA & Deviation reports; acceptance criteria review, ISO and GXP internal audits, and regulatory affairs filings
- Review all quality and regulatory activity pertaining to assays and test method development and protocols
- Initiate and design of change documentation, Device History File (DHR), and Device History Records (DHR/Batch Records), Device Master Record (DMR)
- Facilitate timely review of mission critical documentation and reviewing document drafts for format, clarity, grammar and spelling.
- Engage in activity necessary to foster success for Nanobiosym's Quality Assurance and Regulatory Affairs functions in a cross-functional collaborative manner.
Do You Have?
- A BS/BA degree required, Master's degree (preferred) in a Scientific or Engineering Discipline, with a strong background in such as molecular IVD diagnostics, Biomedical Engineering, Electrical Engineering, Molecular Biology Wet lab Assays solid state diagnostic systems
- 10 or more years of relevant molecular IVD industry experience in an FDA regulated and ISO 13485 compliant environment with a minimum of 2 years management experience in Quality Assurance and Regulatory Affairs.
- Experience in molecular diagnostics assays such a qPCR and RT PCR and Next Generation Sequencing (NGS) quality assurance policies and procedures in an FDA-regulated environment (developer and/or manufacturer of diagnostic tests, medical devices or molecular diagnostics).
- Strong knowledge of applied engineering as it relates to the design, development and production of IVD equipment and reagents (ELISA, Nucleic Acid etc)
- Advanced knowledge and skills in using Microsoft Word, Excel, & Access and Adobe software.
- Highly detail-oriented.
- Excellent communication and organizational skills with the ability to write clearly with proper grammar and spelling.
- High integrity and alignment with the humanitarian mission of the company
We are smart, passionate, fearless, focused and steadfast in our mission. If we're going to rewrite the rules, we have to work hard, and that means we typically work more than a 40-hour workweek. We do it because we love what we do, and we're working to deliver world class healthcare to the over 7 billion people living on Earth today. Our hard work doesn't go unnoticed; we were awarded the first ever XPRIZE for healthcare for which we are immensely proud.
If all of this sounds like it was written for you, we'd love to receive your application and resume.
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