Innitius is developing novel patented medical devices based on torsional wave technology for the diagnosis of conditions or syndromes based on the consistency of the tissue being tested. The company’s initial focus is on improving the outcomes and reducing the costs associated with preterm labor (PTL).
As part of the development plan, Innitius is hiring a QA/RA manager to join the company as soon as possible. Please, feel free to share this article or the attached documents to anybody that fits with the description:
Duties and responsibilities
- Create a regulatory strategy & work-plan.
- Regulatory pre-submissions to EMA & FDA.
- Establish a design history file.
- Establish a risk management file.
- Build relationships with suppliers – manufacturers.
- Establish document controls.
As Innitius is creating its own product, it’ll generate plenty of records, and it’s important to have a system for organizing and maintaining them – they’ll later be reviewed by the FDA, ISO, and possibly others to establish Innitius’ compliance with medical device regulations.
- Technical File & FDA documentation drafting
A. Establish, manage and maintain compliance with FDA QSR, including establishment registration, new product submissions, CAPA System.
B. Establish, manage and maintain compliance with MDD 93/42/EEC directive, including CE Mark applications via Technical Files.
- Implement Manage and maintain compliance to ISO13485 requirements.
- 5+ years’ experience in Quality Assurance and Regulatory affairs within the medical devices field of use
- Understanding of European & American Health Authority regulations, guidelines, policies.
- Ability to maintain a high level of accuracy and attention to detail.
- Effective project management skills.
- Excellent planning, organization, interpersonal, time and change management skills.
Working in Innitius
- Salary: To be discussed with the applicant in base on his/her profile.
- Based-home work is allowed. Home-based work is allowed. Innitius has offices in Granada & Bilbao, so being able to relocate in Bilbao in the future -not necessary immediately- will be considered as a positive point.
Applicants can send CV & Presentation letter either to email@example.com or firstname.lastname@example.org
Marketing Communications Manager at Innitius