Do you want a job with a purpose?
And do you want to make healthcare safer, better and more reliable?
Join our Team!
Join us as our Pre Market Quality and Regulatory Specialist at Dedalus, one of the World’s leading healthcare technology companies, in France in Bordeaux to do the best work of your career and make a profound impact in providing better care for a healthier planet.
As the Pre Market Quality and Regulatory Specialist, you will ensure ongoing Quality and Regulatory compliance as an embedded member of development project core teams (PCTs).
Reporting to the Pre Market Quality and Regulatory Manager, the Pre Market Quality and Regulatory Specialist will ensure, in partnership with business partners, the safety, efficacy and quality of products, medical devices and services offered by DH Healthcare. This is carried out via the sound application of risk management principles and through full compliance with all applicable quality, regulatory and legislative requirements.
You will provide guidance and define regulatory plans and strategies, working with the project core team. He/she will also be accountable for the implementation of the pre-market regulatory procedures and the compilation of regulatory clearance documentation to achieve timely regulatory clearances.
You will be responsible for:
Ensuring process adherence for the pre-market procedures
Completeness of design history files and regulatory submissions
Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams
Creation and maintenance of key regulatory deliverables of the projects
Regulatory and CE submissions in cooperation with regional QARA organizations
Ensuring the adherence to the medical device risk analysis process as risk moderator of the development team
Facilitate regulatory compliance in design control processes to ensure that there are no compliance issues during regulatory inspections.
Performing internal audits and defending Dedalus pre-market activities during external regulatory inspections and audits
Be a QARA ambassador on product teams.
Ability to analyse, understand, and interpret regulations and standards for a more general business audience
Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive, and new Medical Device Regulation MDR and IVDR
o Design control regulations and requirements
o Medical device classification rules and regulations
o Medical device regulatory submission regulations and requirements
o Risk management regulations and requirements
o Software development methodologies and practices
o CAPA/NC regulations and requirements
o Usability, safety, and product related standards
Strong problem solving and project management skills;
Excellent communication (verbal and written), research, organizational and interpersonal skills
Expert PC operation skills, including knowledge of enterprise-wide software applications
Mandatory Language Skills on professional level: English and French
Desirable Requirements
Awareness of Medical Device product safety and Security Standards including ISO 27001, GDPR (Preferable)
Awareness of other regulation as determined by product availability (including ANVISA, CMDCAS, FDA, SFDA)
Ability to work independently towards deadlines and strong attention to detail
Knowledge of Microsoft Office applications required (Intermediate to Advanced preferred)
QMS tools (document & records control systems, regulatory clearances, KPIs) (Preferable)
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 Group’s 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 7,600 people, including around 1,000 people in France, 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: 31th of March 2026
Our Diversity & Inclusion Commitment sets out Dedalus’ approach to ensuring respect, inclusion and success for all our colleagues and the wider communities we operate in. It is imperative for us to share our commitment and dedication to ensure an inclusive and diverse workplace. We recognise that we have improvements to make, and, on this journey, we must remain authentic and realistic but also ambitious.
Our diversity & inclusion commitment – Dedalus Global
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