Do you currently work in the Medical Device industry? Are you an expert in Quality Assurance and Regulatory Affairs? Would you like to work for an exciting, new company to develop and market innovative Medical Devices?
To strengthen our team, we are looking for an experienced and motivated Quality Assurance / Regulatory Affairs Manager.
- Establish and maintain a Quality Management System (QMS) compliant with MDR, ISO 13485, ISO 14971 and FDA 21 CFR Part 820
- Develop and maintain quality assurance procedures and activities to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
- Preparation of documentation for submission for medical device approval and/or response to inquiries from the authorities.
- Ensure regulatory compliance of devices prior to clinical investigations and market launch
- Support project team on product development processes
- Collaborate actively on selection and follow-up of suppliers/production partners
- Supervision and control of device manufacturing.
- Ensure that post-market surveillance and vigilance obligations are met.
- Relevant degree and at least one year of experience in regulatory affairs or quality systems management related to medical devices
- Good knowledge of Medical Device Regulations, ISO13485, 21 CFR 820, ISO 14971, CE and FDA approval processes.
- Excellent English writing skills.
- Structured, dedicated and proactive team player who’s passionate about making quality an integrated part of the company process.
ONiO AS is a Norwegian technology company in rapid growth. As an employee at ONiO you can expect a competitive salary, stock options program and insurance incentives.