Regulatory Affairs & Quality Assurance Professional
We are currently hiring.
- Drive operational Quality Assurance activities for development activities related to Medical Devices
- Provide specific internal QA support for Medical Devices
- Ensure compliance to Medical Devices regulations, ISO requirements, FDA requirements GMP/cGMP compliance from a quality, safety and efficacy point of view
- Managing the Quality Management System according to the EU ISO 13485, the US FDA 21 CFR Part 820 and any other relevant regulatory requirements in accordance with the Quality Policy
- Ensure ongoing awareness of new and developing regulations (different ISO regulations, GMP, GDP, MDR, MDD etc)
- Assuring that products have been supplied, manufactured, analyzed and released according to specifications and approved SOP’s and to appropriate standards and regulations.
- Organizing and documenting the Management Review according to the company QMS. Recommending and driving improvement
- Performing supplier audits, internal and external audits and interacting with suppliers and customers to deal with non-conformities and drive continuous improvement
- Supporting activities for CE marking and FDA approval certification of products as well as maintaining the documentation up to date when changes to the product occur, dealing with notifications and amendments when required
- Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
- Reporting to the management on the effectiveness of the Quality Management System and any need for improvement of the company organization
- Identifying gaps and areas for improvement in the QA processes and lead remedial actions and initiatives, including the creation of procedures
- Maintaining Company training matrix and perform follow-up of training of employees
- Scientific Master’s degree, or equivalent through experience.
- At least 5 years of experience in QA management positions in the medical devices industry.
- Strong understanding of regulations and guidelines governing medical devices (e.g. CFRs, ISO 13485, MDD, MDR).
- Strong leadership, project management and communication skills together with hands-on and pragmatic mind-set.
- Ability to work in a start-up environment where accuracy, accountability, quality, safety and timeliness are essential.
- Highly collaborative, self-motivated and team-oriented individual in a company setting.
- Excellent oral and written communication skills in French and English.
- Eye for details
- Hands-on, “can do” and problem-solving attitude
- Team player, constructive and analytical thinker
Join us today!
Send us your motivation letter and CV (HR@indigomed.com)
We look forward to hearing from you!