Работа в Москве, вакансия - QA & RA Specialist • Москва - id316

𝐃𝐢𝐚𝐠𝐧𝐨𝐜𝐚𝐭 is the global technological leader in AI solutions for Dentistry. Our imaging solutions allow dentists to make fewer diagnostic errors and save time by incorporating computer vision into their workflow.

Diagnocat holds multiple patents, CE mark, and registration in most EU countries. We work in multiple countries and have hundreds of clinics worldwide as our paying customers.

We are looking for a Quality Assurance & Regulatory Affairs Specialist.

Why join us?

• Impact: Your work will directly affect patients’ lives, driving positive change through our innovative products.

• Flexibility: We offer fully remote work.

• Competitive compensation: You’ll receive a fixed monthly salary that reflects your experience and contribution to our mission.

Responsibilities:

• Preparing and implementing quality assurance policies and procedures.

• Identifying and resolving workflow and process issues.

• Ensuring that standards and safety regulations are observed.

• Ensuring all documentation is updated according to requirements.

• Documenting quality assurance activities and creating reports.

• Making recommendations for improvement.

• Creating training materials and managing training.

• Updating suppliers according to requirements.

• The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before the device is released.

• The technical documentation and the EU declaration of conformity are drawn up and kept up to date.

• The post-market surveillance obligations are complied with in accordance with MDR Article 10.

• The reporting obligations referred to in MDR Articles 87 to 91 are fulfilled.

• Act as the company PRRC.

Requirements:

• Certificate in quality assurance is a plus.

• Previous experience in quality assurance or a similar field.

• Working knowledge of tools, methods, and concepts of quality assurance.

• Solid knowledge of relevant regulatory standards (ISO 13485 is a plus).

• Good communication skills, both verbal and written.

• Excellent data collection and analysis skills.

• Strong attention to detail.

• English - at least B2 level.

If you’re ready to unlock your potential and join an innovative team shaping the future of dentistry — we invite you to apply and become part of Diagnocat