Pre-market QARA
Dedalus
full-time
Posted on:
Location Type: Office
Location: Bordeaux • France
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About the role
- Ensure ongoing quality and regulatory compliance as an embedded member of development project core teams (PCTs)
- Collaborate with business partners to ensure the safety, efficacy, and quality of products, medical devices, and services offered by DH Healthcare
- Provide guidance and define regulatory plans and strategies in partnership with the project core team
- Be accountable for implementing pre-market regulatory procedures and compiling regulatory clearance documentation to achieve timely approvals
- Ensure process adherence for pre-market procedures
- Maintain completeness of design history files and regulatory submissions
- Ensure regulatory and process conformance for development and maintenance projects as a member of cross-functional teams
- Create and maintain key regulatory deliverables for projects
- Prepare regulatory and CE submissions in cooperation with regional QARA organizations
- Ensure adherence to the medical device risk analysis process as the development team’s risk moderator
- Facilitate regulatory compliance within design control processes to prevent compliance issues during regulatory inspections
- Perform internal audits and defend Dedalus pre-market activities during external regulatory inspections and audits
- Act as a QARA ambassador on product teams
Requirements
- Ability to analyze, interpret, and communicate regulations and standards to a general business audience
- Subject-matter expert in regulatory affairs with in-depth knowledge of relevant healthcare quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, the Medical Device Directive, and the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
- Knowledge of design control regulations and requirements
- Understanding of medical device classification rules and regulations
- Experience with medical device regulatory submission requirements
- Knowledge of risk management regulations and requirements
- Familiarity with software development methodologies and practices
- Understanding of CAPA and non-conformance (NC) regulations and requirements
- Knowledge of usability, safety, and product-related standards
- Strong problem-solving and project management skills
- Excellent communication (verbal and written), research, organizational, and interpersonal skills
- Advanced PC skills, including knowledge of enterprise-wide software applications
- Mandatory professional language skills: English and French
- Awareness of medical device product safety and security standards, including ISO 27001 and GDPR (preferred)
- Awareness of other regulations as determined by product availability (including ANVISA, CMDCAS, FDA, SFDA)
- Ability to work independently to meet deadlines with strong attention to detail
- Knowledge of Microsoft Office applications (Intermediate to Advanced preferred)
- Familiarity with QMS tools (document & records control systems, regulatory clearances, KPIs) (preferred)
Benefits
- 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 communities.
- Our company fosters a culture where employees are encouraged to learn and innovate, enabling and enhancing clinical cooperation and processes while making a meaningful difference for millions of people around the world.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory complianceregulatory affairsmedical device regulatory submissionrisk managementdesign control regulationsISO 13485ISO 14971IEC 62304IEC 62366CAPA
Soft Skills
problem-solvingproject managementcommunicationorganizational skillsinterpersonal skillsattention to detailindependent workresearch skills