Regulatory Affairs Specialist (MDR, ISO 13485)

As an experienced Regulatory Affairs Specialist, I provide expert guidance and hands-on support for navigating the Medical Device Regulation (MDR) and implementing ISO 13485. I offer comprehensive support to ensure your products meet all necessary requirements for a successful market launch in the EU, UK, Switzerland, and US.

With hands-on experience in implementing both the EU Medical Device Regulation (MDR) and ISO 13485 quality management systems, I help organizations achieve and maintain compliance across the entire product lifecycle.

Whether you are a startup planning your first submission or an established manufacturer optimizing processes for new markets, I provide pragmatic, up-to-date solutions to accelerate your market access and reduce compliance risks.