Quality Assurance Regulatory Affairs Specialist

What youll achieve

As a Quality Assurance Regulatory Affairs (QARA) Specialist you will ensure the respect of the Quality and Regulatory standards throughout the Company making a profound impact throughout the healthcare sector.

You will:

• Participates in problem management teams to assure regulatory conformance by monitoring complaint creation escalation and follow up

• Guide and advise managers regarding compliance issues and ensure that decisions are documented and the company is following the correct processes

• Ensure timely resolution of all complaints and escalated issues

• Provide feedback on product problems and risk evaluation with QARA pre-market and coordinate actions with QARA Services

• Coordinate and conduct Post Market Surveillance Activities Ensuring compliant regulatory reporting for all applicable regulatory agencies and report incidents and trend reporting while respecting their regulated timelines

• Play a leading role in addressing critical product issues and evaluating escalated complaints and problems for risks.

• Identify areas of improvement through the analysis of product issues quality metrics internal audit and customer complaints.

• Report on Post Market activities during Management Review meetings (site level divisional level healthcare level)

• Provide senior-level contributions in making the QARA department a professional proactive dynamic positive and competent workforce

Take the next step towards your dream career

At Dedalus Life flows through our software. Every day we do something special by helping caregivers and health professionals deliver better care to their served communities. Take the next step in your career that will make a profound impact. Heres what youll need to succeed:

Essential Requirements

• Familiar with international regulations and standards pertaining to medical devices development and deployment; familiarity with ISO 9001 ISO 13485 ISO 14971 and ability to interpret and work with regulations and standards

• Exposure to risk management processes

• Knowledge of software development methodologies and practices

• Strong problem solving and project management skills

• Excellent communication (verbal and written) research organizational and interpersonal skills

• Familiar with international regulations and standards pertaining to medical devices development and deployment; familiarity with ISO 9001 ISO13485 and ISO 14971 ability to interpret and work with regulations and standards

• Database and software tool manipulation skills

• Knowledge of statistical techniques and data analysis

• Very good English skills both verbal and written

• University Degree in Engineering Computer science or Science

We are Dedalus come join us

Dedalus is committed to providing an engaging rewarding work experience that reflects the passion our employees bring to our mission of helping clinicians and nurses deliver better care to their served communities.

Our company fosters a culture where employees are encouraged to learn and innovate and to enable and enhance clinical co-operation and processes while making a meaningful difference for millions of people around the world. Each person is the end point and the starting point of the Groups activities and the ultimate beneficiary. For this reason we are so proud of doing our very special jobs each day.

Our company is enriched by a diverse population of 7600 people in more than 40 countries that work together to innovate and drive better healthcare options for millions of patients around the world. We are the people of Dedalus.

Application closing date: 9th September 2025

At Dedalus innovation starts with inclusion. As a company driven by our Core Values we know diversity and inclusion are key enablers for us to succeed and grow. Our international footprint connects people from across the globe and we are committed to celebrating diverse backgrounds skills experiences and creating an environment that reflects the many communities we reach. Pursuing Diversity and Inclusion is one of our Core Values and a part of our Dedalus DNA which drives us to build a respectful diverse and inclusive environment by recognising the unique needs perspectives and potential of all members of our community. Dedalus is proud to promote diversity inclusion equity and equality and is committed to creating a safe and inclusive culture where we celebrate diversity in all forms and empower everyone to be the best they can be.

Our diversity & inclusion commitment Dedalus Global

Life Flows Through Our Software