- Are you methodical, detail oriented, well organized and effective at management?
- Are you passionate about new product development, healthcare and mobile technology?
- 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, quality and compliance and healthcare delivery?
We have a fantastic opportunity at Nanobiosym for an R&D Compliance Engineer who will have ownership for regulatory requirements for compliance through the organization and the coordination of processes.
A Typical Day:
- Partner with cross-functional teams to update the tech files to ensure compliance with IVDD and MDD.
- Collaborate with Quality and Product Design Owners to ensure periodic review of risk management files per internal SOPs.
- Design and develop quality systems metrics to ensure compliance with defined procedures. Implement new performance metrics across all aspects of systems and processes.
- Establish and maintain quality systems and compliance programs, procedures and controls to ensure that the performance and quality of product conforms to the established processes and procedures.
- Partner with product manufacturing engineering, product development engineering and research & development to review and ensure adherence to established procedures.
Do You Have?
- A Bachelor's degree in an Engineering or Life Science discipline or related technical field.
- A minimum of 3 years in the medical device industry with working knowledge of design controls and product development.
- Working knowledge of 21 CFR Part 820, QSR, ISO 13485, and MDD/IVDD requirements.
- The ability to interpret and apply regulatory requirements and industry best practices is required.
- Prior experience working with Risk Analysis and Risk Management.
- Demonstrated ability to be a critical thinker and detailed oriented
- Thrive on overseeing multiple tasks for several projects or base business deliverables.
- Excellent communication skills, both written and verbal.
- Prior experience with Recalls/Field Action management activities,
- Experience and knowledge of CAPA processes.
- Proficiency with computer applications (e.g., PowerPoint, WORD, Excel, Visio) is required, Strong Excel skills are strongly preferred
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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