Quality and Regulatory Affairs Manager

Quality and Regulatory Affairs Manager
RetinAI Medical, Switzerland

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
Qualification
Bachelor's Degree
Total Vacancies
1 Job
Posted on
Sep 11, 2021
Last Date
Oct 11, 2021
Location(s)

Job Description

RetinAI is a fast growing Digital Healthcare company located in Bern, Switzerland, focused on accelerating clinics, research and pharmaceutical workflows in ophthalmology and neuro-degenerative disorders through Artificial intelligence.

Servicing renowned clinical and research partners, we want to expand our QRA team with an experienced Quality and Regulatory Affairs Manager.

The ideal candidate will be responsible for preparing, maintaining and improving the technical documentation in accordance with the internal procedures and the international medical device industry requirements.

The candidate should provide guidance to integrate regulatory considerations into global product entry, to ensure adherence to medical device regulations and to help the company maintaining consistent quality.

We are looking for people who love what they do, have good communication skills, are able to understand the requirements of the field and to contribute with their experience to solve challenging problems in a collaborative environment.

The preferred working location is Bern, Switzerland, where the company HQ is located, but we are strong supporters of mobility and work-life balance!


Things you will do:

  • Conduct design reviews for new releases and maintain the relative technical documentation
  • Manage the design change control and CAPA processes
  • Develop and improve continuous integration for development, testing and releases
  • Interact with the development team to answer Health Authorities requests
  • Communicate and manage documentation, standards and procedures to the development team

Requirements

  • University degree in Biomedical Engineering or Computer Science ideally in imaging or Cloud science
  • Minimum of 5 years relevant work experience, thereof 2 to 3 years of experience in a medical device company and a good understanding of the EN 62304 standard requirements
  • Good working knowledge of quality management system based on ISO standards and EU Medical Devices Regulation, as well as FDA regulations
  • Proven project management skills and ability to manage and communicate with multiple internal and external stakeholders
  • High level of interpersonal skills and autonomy
  • Fluency in English.

Benefits

RetinAI is formed by an exceptional team of entrepreneurs, software developers, researchers and clinicians, working together to develop breakthrough technologies in healthcare, supporting doctors to address some of the leading causes of blindness in the world.

We want to offer candidates the opportunity to work in an exciting and fast-moving field, collaborating with experts in the healthcare of tomorrow. All of this in a pleasant and motivating working environment with a competitive salary.

At RetinAI we support a work-life balance adapted to the employees. We encourage your professional development with training and development in an extremely international environment, and we consider collaboration and equality a pillar of our company culture.

Job Specification

Job Rewards and Benefits

RetinAI Medical

Information Technology and Services - Bern, Switzerland
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