Job Title
Regulatory Affairs Specialist - Medical Devices
About the Job
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in the development and deployment of our regulatory affairs processes.
Your Responsibilities
* International Registration of Medical Devices: Manage the registration process to obtain necessary approvals for marketing our products.
* Technical Documentation: Create and maintain technical documentation, including CE marking files, ensuring compliance with applicable regulatory requirements.
* Quality Management System (QMS): Maintain QMS compliance with regulatory and standards requirements, including ISO 13485, CE marking, and MDSAP certifications.
* Communication: Ensure effective communication with external contacts, customers, suppliers, and internal departments.
* Project Leadership: Lead projects related to implementing new regulatory or normative requirements and contribute to continuous improvement.
* Post-Marketing Activities: Contribute to post-marketing follow-up activities, including product monitoring and reporting.
* Quality and Regulatory Affairs Department Activities: Participate in various department activities, such as maintaining databases, handling vigilance cases, conducting audits, managing modifications, and analyzing data.
Your Profile
* Advanced Scientific or Engineering Training: Degree in a relevant field.
* Professional Experience: 3 years of experience in medical device regulatory affairs.
* Knowledge of Regulations: Familiarity with main standards and regulations applicable to our field, including ISO 13485, EU Regulation 2017/745, and other MDSAP jurisdiction regulations.
* Language Skills: Good written and spoken English, with Spanish or Arabic a plus.
* Soft Skills: Team spirit, analytical skills, pragmatism, proactivity, and excellent communication and interpersonal skills.
What We Offer
* Dynamic Work Environment: Opportunity to work at the cutting edge of industrial automation.
* Professional Development: Opportunities for growth and career advancement.
* Inclusive Culture: Collaborative and innovative corporate culture that values teamwork.
* Benefits: Attractive benefits package, including free parking, home office, flexible hours, and minimum 5 weeks' vacation.
Entry into function: Immediate or to be agreed upon.