Role Mission
Participate in the development and deployment of our regulatory affairs processes and report on their effectiveness and any need for improvement.
Your Responsibilities
- Manage the international registration of medical devices to obtain the approvals needed to market our products.
- Ensure the creation and maintenance of technical documentation applicable to our products (CE marking files) and participate in new product development projects as a representative of the QA-RA function to ensure that applicable regulatory requirements are taken into account and met.
- Actively participate in maintaining the compliance of our quality management system with applicable regulatory and standards requirements, as well as the corresponding certifications (ISO 13485, CE marking, MDSAP).
- Ensure effective communication with external contacts, customers, or suppliers, as well as other departments within the company, and support them in all matters relating to regulatory affairs.
- Lead projects linked to the implementation of new regulatory or normative requirements and contribute to continuous improvement and regulatory and normative watch.
- Contribute to post-marketing follow-up activities (PMS).
- Participate in various activities of the Quality and Regulatory Affairs Department, including maintaining regulatory databases, handling vigilance cases, conducting internal and supplier audits, managing modifications, analyzing data, and handling CAPAs.
- Ensure employee awareness of and training in applicable regulatory requirements.
Your Profile
- Advanced scientific or engineering training.
- Knowledge of the main standards and regulations applicable to our field (ISO 13485:2016, Regulation (EU) 2017/745, 21 CFR Part 820, and other regulations applicable in MDSAP jurisdictions).
- Good knowledge of MS Office tools (Word, Excel, PowerPoint).
- Good level of written and spoken English (B2); Spanish or Arabic would be a plus.
- Team spirit.
- Excellent analytical skills.
- Pragmatism, proactivity, and rigor.
- Excellent communication and interpersonal skills.
We Offer
- A stimulating and dynamic work environment at the cutting edge of industrial automation.
- Opportunities for professional development and career advancement.
- A collaborative and inclusive corporate culture that values innovation and teamwork.
- Attractive benefits, including free parking, home office options, flexible work hours, a minimum of 5 weeks of vacation, and health insurance participation.
Entry into the function: immediately or to be agreed.
If you recognize yourself in this job description, are dynamic, and interested in taking on challenges in a growing company, we look forward to your application. Apply online using the form below. Please note, only applications matching the job profile will be considered.
We look forward to discovering your talent and discussing how you can contribute to our success!