Join our dedicated team and become part of a company applying state-of-the-art technology that establishes an all-new category of glucose monitoring.
At RSP Systems A/S, we are developing a non-invasive glucose measuring device based on Raman spectroscopy and we are transforming how we measure health. To strengthen our development efforts, we are looking for a new colleague, who will work with risk management and regulatory affairs.
Do you want to be part of a team responsible for regulatory approval and registration of the world’s first truly non-invasive glucose monitoring device?
The Risk Manager / RA Specialist is expected to work within the QA/RA department and in close cooperation with our development team. As our Risk Manager / RA Specialist your tasks will include:
- Participate in the development and execution of regulatory strategies.
- Support the design and development team in identifying applicable regulatory requirements, standards, their impact and how to interpret them.
- Assemble regulatory submission package and support submission process.
- Review and ensure compliance of the technical documentation.
- Drive collaboration with other departments to assess, document and mitigate risk(s) for GlucoBeam and be responsible for creating and maintaining risk management files.
- Support development with risk management expert knowledge.
- Participate in other quality assurance tasks, e.g., internal and supplier audits, quality control, in cooperation with the rest of the QA/RA department.
We offer an inspiring, dynamic work environment with an opportunity to work with a wide array of tasks within regulatory, risk management, and quality aspects. Our working environment is informal and characterized by a strong team spirit where each member has an essential role in the development.
As a person, you are open, inquisitive, structured, and knowledgeable, and you thrive in being the key person coordinating risk management activities – with input from the rest of the development organization.
The ideal candidate has worked with FDA quality system regulation 21CFR820, and, preferably with Medical Device Regulation, CE marking and ISO 13485.
We expect you to have a relevant scientific degree (minimum a Bachelor of Science, Engineering or similar), and preferably at least 3 years of experience in regulatory affairs and/or risk management, preferably from the medical device industry.
The ideal candidate:
- Has experience with QSR – US 21CFR820.
- Has experience with PMA, 510(k) or De Novo submission processes in the US.
- Knows of and has experience with ISO 14971 for risk management, preferably for devices that contain software and that are higher than Class I.
- Understand the Medical Device Regulation (EU) and medical device quality standards such as ISO 13485.
- Experience in preparing technical documentation intended to be used for a submission in the US. Knowledge of EU processes is an advantage.
- Pragmatic and holistic approach toward regulatory interpretation and implementation.
- Excellent verbal and especially writing skills in English.
Work location: You will be located in our office in the Southern part of Odense, close to the freeway and public transportation.
Contact and Application
For more information, you are welcome to contact our QA/RA Director, Karen Hvid Ipsen, at email@example.com.
Please submit your application either via mail to our address at Sivlandvænget 27C, 5260 Odense S (address it to HR), in person (to HR), or to our email address firstname.lastname@example.org.
The deadline for applications is on September 30th, 2021, but applications are continuously reviewed.