Assistant, Regulatory and Quality
We are looking for a Regulatory Affairs & Quality Assurance Assistant to join our growing direct-to-consumer medical device organization.
What you’ll be doing:
- Provide day to day, administrative support to the Regulatory Affairs and Quality Assurance departments.
- Assist in the overall management of Regulatory Affairs and the Quality Management System.
- Act as the face of Regulatory Affairs and Quality Assurance, at the Darien, CT office.
- Responsible for Document Control, pertaining to Regulatory Affairs and Quality Assurance documents.
- Drafting of all technical documentation related to Regulatory requirements and Quality Management processes.
- Coordinate with manufacturing partners, suppliers, external consultants, testing laboratories, etc., on issues related to Regulatory, Quality and New Product Development.
- Provide support and scheduling, for all Internal Audit activities, including audits performed by third parties.
- Perform any and all tasks associated with the Darien, CT office and Regulatory, Quality and New Product Development activities.
- Other ad-hoc tasks as assigned by management.
- Degree in Engineering (Biomedical Engineering is preferred)
- A Technical Degree in conjunction with Quality, or other relevant experience will be considered
- Detail Oriented
- Outstanding written and verbal communication skills
- Well organized
- Team player
- Driven and capable of working without direct supervision
- High level of computer and software proficiency
- Proficient in Google Analytics
- Software – Netsuite, MS office, Google App Suite
- Experience in medical device or biomed industry
- Experience with QMS is preferred, but not required.
About CEFALY Technology
Founded in 2008, CEFALY Technology is transforming the approach to migraine pain relief by offering a drug-free, non-invasive treatment option. Our mission — to solve the persistent problem of migraine through advanced therapeutic innovations.
Our proprietary device, the CEFALY DUAL, is an external Trigeminal Nerve Stimulator (eTNS) device, that works by sending tiny electrical impulses through a self-adhesive electrode placed on the forehead to stimulate the trigeminal nerve, reducing the frequency and intensity of migraine attacks.
In 2020, CEFALY DUAL became the first device of its kind available over-the-counter (OTC) in the United States. To date, CEFALY has treated over 2 billion migraines worldwide, and with OTC clearance, that number is poised for significant growth.