QA/RA consultant interested in cyber and information security

At Prevas we are not just second-to-none in the development of products and  technologically advanced solutions. We also ensure that our clients provide products and solutions that are compliant in terms of quality, regulatory affairs and information security - we are with our client all the way to the market. We are driven by our common purpose, that ingenuity will save the world.

For our department in Herlev we are looking for a colleague who loves to work with quality compliance (MDR, ISO 13485), regulatory documentation and challenges as well as information security at the organizational level (ISO 27001, ISO 2702) and the product level (MDCG 2019-16, ISO 81001-5-1, IEC 62443, etc.).

At Prevas we can offer the opportunity to work with a wide variety of compliance related issues across almost every industry. As our new colleague, it is important that you:

• Have a genuine interest in compliance and if you are not an expert in all the areas we have mentioned - you have an interest in becoming one.
• Have knowledge of quality standards, EU or US directives and regulations from regulated industries (MedTech, Pharma, Food, Marine, Wind, etc.).
• Have experience with medical device development or experience from other highly regulated industries.
• Preferably know device safety standards and the standard for medical device risk analysis.
• Take responsibility for your own tasks.

We expect you to have a few years of experience after graduation - we don’t know yet if your educational background is in engineering or an equivalent academic level from a health-related study. We do expect you to be curious and interested in technology

Alternative last sentence above: Interested in working in a technology-driven organization.

In the team for quality and regulatory compliance, none of us has all the answers. But together we answer any question.

About Prevas

We are embedded in our DNA and we are focused on being the preferred provider of embedded development to our customers. We work very closely with our customers, and as a Prevas employee, you will often come into close contact with many different customers’ different functional areas and departments, either as project member at our office in Herlev, or on-site in the customer’s project team.

We have an informal corporate culture with great opportunity for influence as well as great opportunities for personal and competence development in some of the industry’s most exciting and challenging compliance projects. We believe that a balance between work and private life is a prerequisite for efficiency and creativity in the office. In our department in Herlev, we are 40 employees working on development projects and we have an outstanding social community.

Questions?

Please contact Team Manager, André Agerholm via e-mail: [email protected] or telephone: +45 2829 5788.

You can also read more about Prevas at our homepage, and on LinkedIn!