Freelance Regulatory Affairs Consultant

Planet Pharma is currently recruiting for a freelance Regulatory Affairs Consultant to work for a leading clinical trials company. This role is fully remote in Germany. You should also hold significant experience in Regulatory Affairs within Medical Device.

Responsibilities:

• Ensure all medical devices comply with EU regulations including the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
• Provide support for ISO audits, ensuring compliance with ISO 13485 and other relevant standards.
• Prepare and maintain regulatory documentation, including Technical Files and Design Dossiers.
• Manager regulatory submissions and compliance for substance-based devices, ensuring they meet all necessary requirements.
• Manage regulatory submissions and compliance for combination products.
• Ensure regulatory compliance for medical measuring devices.
• Work closely with R&D, manufacturing, and quality assurance teams to provide regulatory guidance throughout the product development and lifecycle processes.
• Monitor changes in medical device regulations and standards and update internal teams accordingly.
• Provide training and support to internal teams on regulatory requirements and best practices.

Education, Experience and Skills:

• University Degree in a scientific or engineering discipline such as Biomedical Engineering, Chemistry, Biology, or a related field. Advanced degree preferred.
• Minimum of 5-7 years of experience in regulatory affairs within the medical device industry.
• In-depth understanding of EU medical device regulations and guidelines. Experience with substance-based devices, combination products, and measuring devices is essential.
• Proven experience in supporting ISO 13485 audits and ensuring compliance.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a team environment.
• Exceptional attention to detail and organisational skills.
• Proficiency in English and German is required.