Pour notre partenaire basé à Genève, nous sommes en charge de renforcer son équipe en Affaires Réglementaires sur la fonction : Design Assurance & Regulatory Affairs Team Leader (H/F).
Design Assurance & Regulatory Affairs Team Leader (H/F)
- Manage compliance to applicable standard processes for products including application and submission to accredited laboratories, reviews of requirements and implementation.
- Manage recognized certification marks processes for products including dossier preparation, submission to accredited agencies, reviews of application and implementation.
- Manage the registration process (EMEA, US, Canada, …).
- Regulatory Survey
- Provide regulatory direction to development project teams as a core team member.
- Develop regulatory strategy for new products.
- Review proposed product changes for impact on regulatory status of the product.
- Interpret and applies MDD + MDR, machinery, RoHS EU directives and FDA regulations to business practices and provide regulatory input, advice and guidance to the organization.
- Manage change notification to notify body process, including authoring and publishing electronic submissions.
- Maintain the CE mark Tech File updated in accordance with products specification creation and changes.
4 years prior RA experience. The occupant's regulatory background should include the medical device area, and preferably should include orthopedic experience. Experience in the areas of drug, biologics, and combination products regulations is also desirable.
A combination of education and experience will be considered.
Personal skills requirements
- Demonstrate strong writing and communication skills.
- Strong attention to details, and ability to multitask.
- Understand the overall business environment, the orthopedic industry and the marketplace.
- Mastery of relevant regulations, ability to stay abreast of regulations pertinent to medical devices.
- Ability to function well as a member of the team and build relationship between QA/RA and other areas of the organization.
- Able to identify and assess business risks for a given regulatory strategy.
- Ability to diplomatically discuss sensitive information with consultants, suppliers, or customers.
- Motivation and commitment to results.
- Ability to apply the Good Manufacturing Practices.
- Present and discuss clinical, design, manufacturing, etc. issues with internal and external personnel (surgeons, distributors, vendors, inspectors, auditors, sales associates, etc.).
- Strong computer skills.
Une atmosphère de travail agréable vous attend en plus d'une activité passionnante, composée de tâches variées au sein d'une équipe jeune et dynamique. Ce poste vous intéresse ? Merci de postuler via notre formulaire en ligne. Nous nous réjouissons de recevoir votre candidature.