Regulatory Affairs Training – Medical Writing

🔥 0 minutes ago

🇩🇪 Germany – Remote

👨‍🎓 Internship

🟡 Mid-level

🟠 Senior

✏️ Content Writer

👻 Ghost score 12%

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MEC-ABC Medical Care and Product Development

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2016

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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

• Training in regulatory fundamentals and the professional preparation of medical and scientific texts • Training in the fundamentals of medical technology and product development • Training in Regulatory Affairs, the EU Medical Device Regulation (MDR), and approval procedures • Training in international approval procedures for the United States, Asia, and Latin America, as well as MDSAP • Preparation of medical and regulatory texts during a practical training phase • Individual feedback from experienced instructors • Training in Medical Writing, quality management, risk management, clinical evaluation, and clinical studies • Training in technical documentation, project management, innovation and development processes, and Post-Market Surveillance • Virtual live classes Monday through Friday from 8:30 a.m. to 3:30 p.m. over 3 weeks, or 15 days • Preparation for entry-level and specialist roles in Regulatory Affairs, regulatory submissions management, quality management, Clinical Affairs, and Medical Writing

🎯 Requirements

• University degree in Life Sciences, Engineering, Informatics, or a related field, or several years of professional experience • German and English language skills at B2 level (language proficiency is mandatory) • Formal eligibility requirements for funding through the Federal Employment Agency or Jobcenter must be met

🏖️ Benefits

• 100% funding through an education voucher issued by the Federal Employment Agency or Jobcenter • Career and one-to-one coaching • Practice-oriented course structure with a strong focus on hands-on training • Individual support and personal coaching • Virtual classrooms and workspaces • Excellent preparation for entering the profession • Certificate of participation covering all course content upon successful completion • Work samples upon successful completion