Regulatory Affairs International – Medical Writing Training Program

🔥 16 hours ago

🇩🇪 Germany – Remote

⏰ Full Time

🟡 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 for medical devices • Preparation of medical and scientific texts • Content covering medical devices and product development • Training in Regulatory Affairs, the MDR, and approval procedures • Training in international approval procedures in the United States, Asia, and Latin America, as well as MDSAP • Preparation of clinical and regulatory documents in Medical Writing • Training in quality management in accordance with ISO 13485 • Training in risk management in accordance with ISO 14971 • Training in clinical evaluation and clinical studies • Training in technical documentation and project management • Training in innovation and development processes, as well as Post-Market Surveillance • Active drafting of medical and regulatory texts during the practical training phase • Individual feedback from experienced instructors • Live virtual classes Monday to Friday, from 8:30 a.m. to 3:30 p.m. • Preparation for entry-level and specialist roles in Regulatory Affairs, regulatory approval, 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 and application documents must be reviewed • Participation in a free consultation to assess suitability

🏖️ Benefits

• 100% funding through an education voucher (Employment Agency / Jobcenter) • Career guidance 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 • Certificate of participation covering all course content upon successful completion • Work samples upon successful completion