RA Engineer

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 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
• Ensures 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, 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 at: rh@fkg.ch.

We look forward to discovering your talent and discussing how you can contribute to our success !