Careers
Join the MVision AI team and embark on an incredible career journey
Why MVision AI
What started as a small team of two software engineers, a medical physicist, and an AI research scientist in 2017 has grown into an elite team of 30+ dedicated professionals working together to revolutionize radiotherapy.
Don’t find a suitable position? Feel free to send us an open application with a CV to career@mvision.ai. If you’re looking for a tech position, please make sure to add also a link to your GitHub or other portfolios.
Open positions
1. Regulatory Affairs Manager
Location: Helsinki, Pikku Huopalahti and remote
Job Type: Full-time, Permanent
Who we are
MVision AI was born out of a deep desire to harness AI in winning the war on cancer. We exist because cancer patients deserve the best treatment possible, which can only be achieved by providing clinicians with the finest, most reliable tools we can to improve their workflow and help them to focus on patient care. Clinics and hospitals also need to be able to use their limited resources more effectively and meet the official standards to ensure the highest quality cancer treatment.
Job Overview
We seek a highly motivated and experienced Regulatory Affairs Manager. This is a key role responsible for product registration for global markets and continuous improvement of our quality assurance practices and meeting regulatory requirements. You will also be responsible for reviewing and accepting product marketing material from the regulatory perspective.
Role Responsibilities
- Maintain and manage a robust medical device QMS in compliance with regulatory and customer requirements
- Assist with managing new and existing product registrations for global markets
- Assist with documentation required for regulatory submissions and active participation in regulatory meetings and answering queries
- Maintain and manage compliance with EU MDD, MDR , US FDA 21 CFR Part 820 and MDSAP Regulations
- Ability to understand the Product life cycle procedure and Validation studies
- Collaborate with cross functional departments to integrate quality and regulatory requirements into the Product development process and label updates in compliance with country specific regulatory requirements
- Review of product technical documentation and assist in successful product release timelines
- Track and keep procedures up to date with the regulatory guidelines and legislation changes
- Provide regulatory training in a timely manner
- Plan and manage internal and external regulatory audits
Qualification And Experience
- Maintain and manage a robust medical device QMS in compliance with regulatory and customer requirements
- Assist with managing new and existing product registrations for global markets
- Assist with documentation required for regulatory submissions and active participation in regulatory meetings and answering queries
- Maintain and manage compliance with EU MDD, MDR , US FDA 21 CFR Part 820 and MDSAP Regulations
- Ability to understand the Product life cycle procedure and Validation studies
- Collaborate with cross functional departments to integrate quality and regulatory requirements into the Product development process and label updates in compliance with country specific regulatory requirements
- Review of product technical documentation and assist in successful product release timelines
- Track and keep procedures up to date with the regulatory guidelines and legislation changes
- Provide regulatory training in a timely manner
- Plan and manage internal and external regulatory audits
We Offer
- Maintain and manage a robust medical device QMS in compliance with regulatory and customer requirements
- Assist with managing new and existing product registrations for global markets
- Assist with documentation required for regulatory submissions and active participation in regulatory meetings and answering queries
- Maintain and manage compliance with EU MDD, MDR , US FDA 21 CFR Part 820 and MDSAP Regulations
- Ability to understand the Product life cycle procedure and Validation studies
- Collaborate with cross functional departments to integrate quality and regulatory requirements into the Product development process and label updates in compliance with country specific regulatory requirements
- Review of product technical documentation and assist in successful product release timelines
- Track and keep procedures up to date with the regulatory guidelines and legislation changes
- Provide regulatory training in a timely manner
- Plan and manage internal and external regulatory audits
If you have any queries or would like to know more information of this role please contact Kalpana Jha at kalpana.jha@mvision.ai.
Please send your application and CV in English to career@mvision.ai before 29th September 2023.
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