The Quality and Regulatory Affairs Engineer (QARA Engineer) is responsible for organizing, documenting and ensuring all aspects of product compliance throughout the product lifecycle, and supporting the organization with product safety and compliance.

The job holder reports to Regulatory Affairs Manager

Responsibilities

• Ensure safety, performance, effectiveness and quality/regulatory compliance of assigned products and services, including third party products and services, in all the markets where these products are marketed, distributed, sold, supplied, installed, and serviced.
• Enable sales growth by gaining and maintaining regulatory access to the markets that Ascom has decided to supply to, and by effectively fulfilling regulatory requirements with common, consistent interpretations.

Key tasks

• Support development, implementation, maintenance, and improvement of the Management System.

• Support safety, performance, effectiveness and regulatory compliance of assigned products and services across applicable global markets, including but not limited to compliance with MDR 2017/745, 21 CFR 820, ISO 13485, ISO 9001, and ISO/IEC 27001.

• Support maintenance of the regulatory conformity, certifications and approvals for assigned product and related services

• Support product development teams to ensure regulatory compliance of design and development processes with procedures, methods and tools.

• Support creation and review of product documentation, technical file, procedures, work instructions and templates related to Quality & Regulatory activities.

• Participate in and advise on Product Risk Management for assigned projects in accordance with ISO 14971.

• Support with regulatory evaluation in post market surveillance activities, vigilance, and adverse event reporting activities including handling of nonconformities (CAPA and NCR).

• Support regulatory submissions (e.g. 510(k)) as needed.

• Participate in QA/RA audits as needed.

Requirements

Qualifications and Work Experience

• Bachelor's degree in Engineering or Science

• Experience with product development, manufacturing, quality assurance and/or regulatory affairs for medical devices

Skills and Competencies

• Strong computer skills, specifically strong command of Microsoft Office and tools used for product creation, quality assurance and compliance, such as design controls, complaint and non-conformity handling, including but not limited to Agile PLM, SharePoint and JIRA.
• Knowledge of the US FDA QSR, EU MDR, and of medical device process standards during design, development and post-market phase (preferably also alarm systems (IEC 60601-1-8)), usability engineering (IEC 62366-1), risk management (ISO 14971) standards and guidance regarding clinical evaluation, cybersecurity and post market surveillance also considered as an advantage)
• Analytical and communication skills research methodology and scientific writing
• ICT skills and knowledge in Microsoft Office
• Willingness to travel on occasional level
• Very good knowledge of English written and spoken
• Experience with the following management systems: ISO 13485, ISO 9001, ISO/IEC 27001 and in quality audits would be an advantage
• Ability to multitask product, project and region / site level priorities.