Regulatory Affairs Director

hace 3 semanas

Barcelona, España Consult Search A tiempo completo

**Scope**:
A fantastic opportunity has presented itself to join a globally renowned ‘pure play’ Aesthetic Company. Due to the rapid growth of this business, our client are seeking a high calibre Regulatory Affairs Director to join their team in Barcelona. This establishment has a portfolio of differentiated, complementary aesthetic technologies with a focus on collagen stimulation. Their products are experiencing significant growth as they target clinical demand for effective, high quality, longer duration, natural-looking & mínimally invasive treatments.

**Responsibilities**:

- Responsible for planning, directing, coordinating, and controlling the regulatory affairs activities.
- Work closely to the Global Head of Regulatory when analysing and defining regulatory pathways for strategic projects.
- Develop global regulatory strategies for new and modified medical devices.
- Provide leadership to cross-functional teams during new product development.
- Manage technical guidance and training to cross-functional teams and other RA members including training on procedures, FDA, MDR guidance documents, and international regulation.
- Manage activities aimed at obtaining/maintaining the medical CE marking and marketing licenses for energy devices in the different markets worldwide, as well as managing the registration and internationalization processes.
- Manage the Regulatory Affairs team in the different locations.
- Responsible for global submissions and requirements related to medical devices.
- Be integral member of the Post Market Surveillance Team. Ensure compliance with product post-marketing approval requirements.
- Coordinate submissions for new devices and device change notifications as required.
- Review protocols and reports to support regulatory compliance and submissions.
- Approve device labelling for compliance with US, EU and International submissions and applicable regulations.

**About You**:

- University degree preferably in Life Sciences, Engineering, or other technical discipline.
- Minimum 6+ years of experience in a managerial role as Regulatory Affairs Manager/Director in the Medical Devices industry.
- Vast knowledge of: U.S. Food and Drug Administration (FDA) regulatory pathways and MDR EU regulation.
- Mandatory strong knowledge of: ISO 13485, IEC 60601, ISO 14971, IEC 62304, ISO 10993.
- Excellent computer skills (including but not limited to Windows and MS Office).
- Orientation towards achievement and ability to learn

Managed by Oliver Allen

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