Regulatory Affairs Manager

Regulatory Affairs Manager – Software as a Medical Device (SaMD)

Location: Germany (Remote)

I am currently seeking an experienced Regulatory Affairs Manager who holds experience with SaMD or SiMD.

• Regulatory Strategy: Develop and implement strategies for SaMD compliance.
• Submissions: Prepare and manage European regulatory submissions
• Compliance: Ensure ongoing compliance with FDA, EMA, and other regulations.
• Documentation: Maintain regulatory documentation and reports.
• Collaboration: Work with engineering, quality, and product teams to integrate regulatory requirements.
• Regulatory Intelligence: Stay updated on regulatory changes and communicate updates.
• Training: Provide regulatory training and support to internal teams.

Qualifications:

• Bachelor's degree; advanced degree preferred.
• Experience in regulatory affairs for SaMD or SiMD products.
• Knowledge of global regulatory requirements. Also hold strong technical knowledge of IEC 62304 and ISO 27001 standards
• Strong documentation, communication, and project management skills.
• Detail-oriented with analytical and problem-solving abilities.

If you are interested in continuing your journey in SaMD please click apply as i would love to speak with you about this exceptional company.