QARA Consultant for Medical Devices

Looking for a new challenge? Ready to grow your expertise?

Are you passionate about regulatory and quality affairs in the medical device industry?

Do you enjoy working on innovative, high-tech projects in an international environment?

Are you eager to develop your expertise while making a real impact on patients’ lives?

If so, CSDmed is looking for you!

Who we are

CSDmed is a fast-growing consulting company specializing in medical devices and combination products. We are based in Monaco and currently expanding internationally.

We are opening a new subsidiary in Bucharest, and this position will be part of the founding team. Our mission is to help clients bring safe and effective medical innovations to market, and we’re building an agile and dynamic team to support that mission.

By joining us, you will be part of a unique opportunity to help shape our presence in Romania, working on diverse international projects in a flexible and empowering environment. You will have a Romanian employment contract, and work closely with the founder and our global clients.

Your Role & Responsibilities

As a QARA Consultant, you will play a key role in supporting our clients throughout the product lifecycle. You’ll be working directly with the founder, as well as with client teams, ensuring that regulatory and quality requirements are met. While autonomy is key in this role, you’ll always have support when needed, and we’ll tackle challenges together.

Your main responsibilities will include:

Regulatory Affairs

•               Define regulatory strategies based on the client’s product and target markets.

•               Prepare and compile CE marking and international registration files (FDA in US).

•               Support interactions with regulatory authorities and respond to their questions.

Quality Assurance

•               Ensure compliance with ISO, MDR, and other applicable regulations.

•               Contribute to Quality Management System (QMS) improvements and compliance updates.

•               Participate in audits and support clients in remediation actions.

Product Development & Risk Management

•               Contribute to design control processes, including risk management and usability activities.

•               Support biological evaluation, sterilization validation, stability testing, and verification activities.

•               Work closely with R&D, Clinical, and Manufacturing teams to ensure regulatory and quality requirements are met.

As the first team member in Romania, you will also act as the local manager of our Romanian entity and will report directly to the company’s leadership based in Monaco.

You will help shape the local operations, contribute to building the team, and ensure alignment with our global strategy.

You will gain hands-on expertise in an evolving industry, with real opportunities to grow and make an impact.

Your Profile

Education & Experience

•               Master’s degree in Biomedical Engineering, Industrial Microbiology, Biotechnologies, or a related field.

•               Minimum 8 years of experience in medical devices or combination products.

•               Experience working with cross-functional teams in a regulated environment.

Skills & Knowledge

•               Familiarity with ISO, MDRIVDR, and other medical device regulations.

•               Understanding of risk management (ISbiological evaluation (ISusability (IEC 62366) is a plus.

•               Strong analytical and problem-solving skills.

•               Fluency in English (spoken & written), French proficiency is a strong advantage.

Mindset & Attitude

•               Curious and eager to learn – you thrive in a constantly evolving environment.

•               Proactive and solution-oriented – you don’t just identify problems, you help solve them.

•               Thrive in a supportive environment – We value learning, teamwork, and professional growth.

🚀 Ready to take the next step?

Excited to join us? Let’s talk! Send us your application, including your salary expectations, and let’s explore how you can contribute to CSDmed’s journey.

🔗 Contact

Guillaume Valenzuela (founder)

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