Director Regulatory and Quality Assurance
Director Regulatory and Quality Assurance
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Salary Not Disclosed
1 Vacancy
Job Description
THE COMPANY
This innovative MedTech company part of a renowned French industrial group specializes in the design development and commercialization of FLASH radiotherapy systems.
Its mission is to expand the use of radiotherapy in oncology and develop breakthrough treatments for cancer patients.
The company is entering a key growth phase and is looking to structure its RA/QA strategy. Reporting directly to the COO the Director of Regulatory Affairs & Quality Assurance will play a central role in building the quality system securing ISO 13485 certification and preparing the first CE marking submission.
THE OPPORTUNITY
In this strategic leadership role youll have the opportunity to build and drive the entire RA/QA function from the ground up with full ownership of ISO 13485 certification and the first CE marking file. Youll work in a collaborative agile environment that values initiative impact and expertise.
Take your career to the next level in a mission-driven scale-up backed by a major French industrial group where innovation meets purpose.
KEY RESPONSIBILITIES
- Define the quality and regulatory strategy / KPIs and ensure regulatory compliance.
- Promote a strong quality and regulatory culture across the organization.
- Responsible for CE marking and international registrations of medical devices for new products and changes: manage technical documentation and regulatory watch.
- Act as the main point of contact with Notified Bodies.
- Serve as Person Responsible for Regulatory Compliance (per Article 15 of MDR 2017/745) and as Management Representative (as defined in ISO 13485 and 21CFR820).
- Oversee the Quality Management System (QMS) HSE policy and certification audits.
- Responsible for NC/CAPA and PMS processes.
- Manage the QARA team.
PROFILE
- Scientific or technical background with a Masters degree (Bac 5).
- At least 10 years of experience in Quality and Regulatory Affairs within the medical device industry.
- Strong knowledge of applicable regulatory frameworks for medical devices (ISOCFR820 MDR 2017/745).
- Experience in complex negotiations with Notified Bodies and international competent authorities (Europe USA etc.).
- Fluent in English.
- Minimum 5 years of experience in team and project management.
- Strong collaboration skills and ability to work effectively in cross-functional teams.
- Ability to explain regulatory requirements clearly and to implement procedures and internal corrective/preventive actions.
Employment Type
Full Time
