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Job Reference: 7ad8c7cc6443
Job Views: 4
Posted: 15.02.2025
Expiry Date: 01.04.2025
Job Description:
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 your 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 implementation of new regulatory or normative requirements and continuous improvement and contribute to regulatory and normative watch.
* Contribute to post-marketing follow-up activities (PMS).
* Participate in various activities of the Quality and Regulatory Affairs Department, in particular: maintaining regulatory databases, handling vigilance cases, conducting internal and supplier audits, managing modifications, analyzing data, handling CAPAs.
* Ensure employee awareness of and training in applicable regulatory requirements.
Your profile
* Advanced scientific or engineering training.
* 3 years' professional experience in medical device regulatory affairs.
* 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, 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 (free parking place, home office, flexible work hours, minimum 5 weeks’ vacation, health insurance participation).
Entry into 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, then we look forward to receiving your full application.
We look forward to discovering your talent and discussing how you can contribute to our success!
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