Further Training in Regulatory Affairs International, Medical Writing

🔥 45 minutes ago

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MEC-ABC Medical Care and Product Development

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2016

📋 Compliance

🤝 B2B

Compliance • B2B

MEC-ABC Medical Care and Product Development is a Germany-based regulatory consulting firm specializing in clinical evaluation and regulatory compliance for medical devices under the EU Medical Device Regulation (MDR 2017/745). The company supports manufacturers with Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), PMCF and PMS strategies, technical documentation, claim management, deficiency analyses, and clinical study planning to achieve CE conformity and streamline Notified Body interactions. They also offer educational resources (whitepapers, minikurs, consultation hours) and template packages to help clients reduce time and cost in the certification process.

📋 Description

• "Specialist for Technical Research, Development & Regulatory Documentation in Medical Technology" • Teaching regulatory fundamentals and preparing medical and scientific texts • Practical phase with feedback from experienced instructors • Preparation for entry-level and specialist roles in Regulatory Affairs, Medical Writing, and Quality Management

🎯 Requirements

• University degree in Life Sciences, Engineering, Informatics, etc., or several years of professional experience • German and English at B2 level (language skills are mandatory)

🏖️ Benefits

• 100% cost coverage through an education voucher (Federal Employment Agency / Jobcenter) • Career and one-on-one coaching • Practice-oriented course design with a strong training component • Individual support and personal coaching • Virtual classroom and workspaces • Excellent preparation for entering the profession