As an RA expert at BioVision, you serve a wide variety of clients in the medical device industry. You will be part of a team of medical device experts, dedicated to supporting our clients. You might be involved in:

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• Developing the regulatory strategy to facilitate quick market access and minimize the regulatory burden.

• Writing or reviewing technical documentation.

• Perform compliance assessments of technical documentation against European MDR 2017/745 requirements.

• 510(k) submissions for US Market access.

• Lead or participate in MDR implementation projects.

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You work with a variety of devices, for manufacturers, either from home or at the client’s site. Sometimes working alone, or in a team.

We put the best available expertise together. Your learning curve is steep as you work at the forefront of medical technology innovation and with some of the world’s leading device manufacturers. If you are challenged for solutions in a project, there is always a colleague in the BioVision team who can assist.

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This is what you will bring:

• You have a technical or scientific degree (BSc, MSc or PhD) biology, biomedical technology or similar.

• At least 8 years of working experience in the field of medical devices (EU-MDD and EU-MDR) through positions in industry, consultancy, in regulatory roles (e.g. Director / Manager Regulatory Affairs).

• Knowledge of Medical Device Regulations (EU MDR, FDA, HC, TGA, etc.).

• Familiar with writing technical documentation and regulatory documents.

• Communicative and service-oriented, supporting a wide variety of clients from small start-ups to large multinationals, able to adapt to different company cultures and situations.

• Strong organizational skills, detail-oriented to deal with various projects at the same time.

• Competent in communication, analysis, and advice and taking ownership in your work and personal development.   

• Fluent in English.