Regulatory Affairs International – Medical Writing Training Program

This is a fully remote position, open to applicants in Germany.

📋 Description

• Instruction on the fundamentals of regulations concerning medical devices

• Development of medical and scientific documentation

• Content related to medical devices and product development

• Education in Regulatory Affairs, the Medical Device Regulation (MDR), and approval processes

• Training on international approval procedures in the United States, Asia, and Latin America, including MDSAP

• Creation of clinical and regulatory documents in Medical Writing

• Instruction on quality management in alignment with ISO 13485

• Education in risk management according to ISO 14971

• Training in clinical evaluation and execution of clinical studies

• Instruction on technical documentation and project management

• Training in innovation and development processes, along with Post-Market Surveillance

• Active involvement in drafting medical and regulatory documents during the practical training phase

• Personalized feedback from experienced instructors

• Live virtual classes held Monday to Friday, from 8:30 a.m. to 3:30 p.m.

• Preparation for entry-level and specialist positions in Regulatory Affairs, regulatory approval, quality management, Clinical Affairs, and Medical Writing

⛳️ Requirements

• A university degree in Life Sciences, Engineering, Informatics, or a related discipline, or several years of relevant professional experience

• Proficiency in German and English at a B2 level (language skills are essential)

• Review of formal eligibility criteria and application documents is required

• Participation in a complimentary consultation to evaluate suitability

🏝️ Benefits

• Full funding through an education voucher (Employment Agency / Jobcenter)

• Career counseling and individualized coaching

• Practical course structure with an emphasis on hands-on training

• Personalized support and individual coaching

• Access to virtual classrooms and workspaces

• Certificate of participation that encompasses all course content upon successful completion

• Work samples provided upon successful completion