We are seeking a freelance Senior Medical Device Consultant with experience in class I-III medical devices and software as a medical device (SaMD). The successful candidate should have a thorough knowledge and understanding of the Software Life Cycle processes, be able to conduct thorough technical documentation reviews of SaMD and devices using AI/Machine Learning (ML) and ensure compliance with EU/UK regulations and standards. The Senior Medical Device consultant will collaborate with client teams and review technical files and technical documentation.

Qualifications

Bachelor's degree in a related discipline (i.e., engineering, or other relevant sciences)

Extensive professional experience in quality assurance and regulatory affairs for medical devices, with a proven track record of successful EU MDR submissions and bringing devices to the EU.

Strong knowledge of EU/UK MDR regulations.

Proficient in managing technical files and documentation, including risk analysis, design control, and active devices.

Familiarity with medical device software regulations and standards, such as IEC 62304 an Medical device Software requirements.

Strong analytical and problem-solving skills, with the ability to assess complex regulatory requirements and develop appropriate strategies.

Excellent written and verbal communication skills, with the ability to effectively communicate regulatory requirements and recommendations to cross-functional teams.

Detail-oriented with a high level of accuracy in regulatory documentation and submissions.

Ability to work independently and collaboratively, managing multiple projects and priorities simultaneously

Excellent written and verbal communication in English.

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