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Regulatory Affairs and Quality Engineer (QARA-CDI)
As soon as possible
Electroducer is a startup founded in 2017 by the interventional cardiologist Benjamin Faurie, focusing on designing, developing, and commercializing a IIa disruptive medical device integrating the minimalist approach to simplify and secure percutaneous valves implantations (aortic, mitral, tricuspid) and complex coronary interventions.
Guided by the challenging economic and regulatory context and by the founder’s vision focused on the patient, Electroducer is supported by partnerships with internationally renowned experts, hospitals and industrial partners.
In this context, we are looking for a motivated, passionate and experienced person, whiling to work in a small team where the closeness between the Management and co-workers encourages individual autonomy and the power to work together, to fill a permanent position as an experienced Regulatory Affairs and Quality Engineer.
The company is based in Grenoble, a French Alps dynamic pole in the Medtech industry.
PURPOSE OF THE POSITION
Supervised by the CEO and working in a small team of 2 (Regulatory Affairs and Clinical Manager;Product Manager), your missions consist in:
- Ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements,
- Ensuring QMS compliance with regulatory requirements.
ROLE & RESPONSABILITIES
You missions will be divided into two areas of activities:
- support for activities related to the proper consideration of standards and regulations in the context of the development, manufacturing and marketing of medical devices
- represent the regulatory affairs function for the purposes of implementing the quality management system (risk management, CAPA, change control, etc.)
- responsible for managing the technical documentation of the product for CE marking or non-CE approvals, ensure product Technical Files are maintained and updated
- support to the clinical affairs department for the constitution of clinical investigation request submission files
- interact with project teams to provide regulatory guidance with respect to product development and change control processes
- definition of specifications from regulatory and normative requirements for design and development, participate to the risk management process
- management of product labeling requirements
- maintain current knowledge of relevant regulations and standards, carry out regulatory and standards monitoring as well as materiovigilance monitoring, and formalize the gap analysis between the versions of standards and regulations
- in relation to various services (marketing, communication), ensure the adequacy of the documentation with the applicable regulatory requirements and provide regulatory support in specific projects:
- participate in post market activities
- participate in the monitoring actions of products
- participate in the reporting of incidents to the competent authorities
- participation in the development and implementation of the QMS
- management of non-conformities, CAPA, derogations on your area of intervention
- review and approval of documents from the design and development team
- manage internal/external and regulatory audits
- Materiovigilance responsible
- Person responsible for Regulatory Compliance (PRRC)
- Bac + 5 or more in regulatory affairs and quality
- 10 years of experience in regulatory affairs / quality in medical devices industries.
- Good written and oral skills in English
- Knowledge of Quality and Regulatory requirements applied to Medical Devices Industries
- Good knowledge of CE marking and FDA submissions
- Experience of CE audits, FDA inspections
Others (Behavior Skills, Managerial Skills…):
- A passion for patient care
- Strong interpersonal skills including communication, collaboration / team player
- Ability to work autonomously
- Customer and consumer focus
- Ability to network at multiple levels within and outside the organization
- Drive for results
- Priority setting
- Ability to federate