Quality Assurance and Regulatory Affairs Specialist

3 days ago

ClujNapoca Metropolitan Area, Romania Ascom Full time 15,000 - 30,000 per year

Ascom is a global solutions provider focused on Healthcare ICT and mobile workflow solutions. Headquartered in Switzerland, we operate in 19 countries and have been supporting the healthcare industry for more than 160 years.

Our solutions are trusted by 12,000+ hospitals worldwide, handling 800 million alerts every year, over 2 million alerts daily. Every day, our systems positively impact the lives of patients, families, and healthcare professionals across the globe.

The Role

As a Quality Assurance and Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance across Ascom's products, processes, and services. You will support product safety, performance, and effectiveness throughout the entire lifecycle, ensuring that Ascom solutions meet global, regional, and local regulatory standards.

Your work will directly support market access, helping Ascom deliver innovative healthcare solutions worldwide.

Key Responsibilities

  • Ensure compliance of products and services with relevant regulations and standards (e.g. MDR, RED, EMC, FDA QSR, ISO 13485, ISO 9001).
  • Support regulatory submissions (e.g. MDR/510(k)) for medical devices and type approvals for ITE devices.
  • Maintain Ascom's regulatory library and manage purchase of standards and certifications.
  • Contribute to development, maintenance, and improvement of the Integrated Management System (IMS).
  • Review product and process changes for regulatory compliance.
  • Provide QA/RA input to R&D and product development teams, ensuring accurate technical documentation and declarations of conformity.
  • Support post-market surveillance, vigilance, and field corrective actions/recalls as required.
  • Participate in audits, risk management activities, and CAPA processes.
  • Stay up to date with evolving regulatory requirements and support internal awareness.

What You Bring

Education & Experience

  • Bachelor's degree in Engineering, Biomedical Technology, or a Scientific field, or equivalent.
  • 1–2 years + of experience in Quality Assurance or Regulatory Affairs within a regulated industry (or equivalent relevant education) is preferred but not mandatory. Strong graduates or juniors with relevant education will also be considered.
  • Knowledge of regulatory standards for Medical Devices, Radio Devices, and/or ITE Equipment.

Key Competencies

  • Knowledge of regulatory frameworks (MDR, RED, LVD, FDA QSR).
  • Familiarity with safety standards, EMC, cybersecurity, risk management, and device certification.
  • Basic understanding of clinical workflows in healthcare environments.
  • Strong customer focus and ability to see regulatory requirements in the context of customer value.
  • Solid problem-solving skills and ability to work effectively across global and regional teams.

Why Join Ascom?

  • Be part of a global healthcare technology leader driving real-world impact.
  • Gain exposure to international regulatory frameworks and diverse projects.
  • Collaborate with a team that values quality, compliance, and innovation.
  • Build your career in a company that combines a rich heritage with forward-looking technology.

Apply today to help us ensure that Ascom's solutions continue to meet the highest standards of quality and safety while transforming healthcare delivery worldwide.

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