QA/RA Specialist
Quality of life matters. It’s as simple as that. Do you want to be a part of an amazing team whose sole purpose is to help and improve the lives of people living with insulin-requiring diabetes? Do you have the respect, the patience and drive to be a part of a medically restricted environment, willing to make a change?
The role and tasks you are about to consider:
We are looking for a full time QA/RA Specialist. The key impact of this position is to ensure to gain and maintain compliance within key markets and build a strong connection between the QA/RA and the rest of organisation. Being Hedia´s representation towards policy makers is also one of the responsibilities.
Among a great variety of tasks you will first and foremost be guiding the interdisciplinary team in implementation and execution on Medical Device Regulation (MDR) requirements, as well as assisting when needed to maintain compliance with ISO 13485 and ISO 14155.
You will be consulting management and team in assessing regulatory pathways in key markets as Germany, UK and US, along with regulatory approvals and clearances in those key markets.
In addition you will be working with quality assurance matters as complaint handling, CAPA and NC management and performing management reviews. You will serve as QA/RA team member for promotional materials review, clinical investigations design, risk management and product labelling.
Finally Hedia is a Software as a Medical Device, so an interesting part of your everyday responsibilities will be figuring out and establishing a clear roadmap for bringing new technologies that include artificial intelligence components into key markets and coordinating with the clinical team of Hedia on what evidence to generate.
💡 Are you a (QA/RA) professional? You need to keep your finger on the pulse of what’s happening in the medical device industry and explore great career opportunities like this one 🙂
Do you see yourself in the following description?
You are a problem solver who can find solutions to issues that become blocks for others. You are an active listener and have good interpersonal skills – you will work with a wide variety of professions like developers, health and commercial professionals and designers and it is crucial that you can communicate well with everyone.
Finally you have the dedication to patient safety and quality of healthcare and a strong commitment to the organization’s values and vision. They believe that the people in Hedia are what makes Hedia what it is. Therefore we aspire to have an open and welcoming culture where we help each other thrive.
We need you to have:
👉Some years of working experience within medical devices, preferably in Software as a Medical Device (SaMD)
👉Experience from working within regulatory affairs in a medical device environment
👉Experience with CE marking under MDD/MDR and FDA clearances and maintenance of regulatory compliance
👉Experience with performing of internal audits will be a great plus
👉Strong written and verbal communication skills in English
What we offer
- On-going career development, coaching and training (we do not expect you to know everything from the beginning)
- Responsibility and influence on the journey on the QA/RA area in Hedia
- Being part of a purpose-driven company with many happy users
- Social activities, Friday bars and great coffee
- Flexible working hours and a mix between office days and remote working days
- An assigned mentor to support your journey with Hedia
💡 We believe that it’s really important to come up with core values that you can commit to. Thus we all connect into doing something with a passion.
About the hiring process
Kold+Partners is handling the recruiting process. Our process is fast, transparent and tailored to your needs. We are conscious of your time and the fact that you are busy in your daily life. If you have any questions regarding the job or Hedia, feel free to contact Veronika Dimitrova.
Contact info
About Hedia
Hedia is a Digital Therapeutics company working to improve the lives of people living with diabetes. With our medical software, we aim to create the best experience for every user on the platform. Hedia was founded to help with the problems of people with diabetes. Every day our team works hard to create effective health services for our users. The platform is available in more than 10 countries and we are currently expanding to other countries as well.