Medical Software CE Marking Specialist

Job Title:
Medical Software CE Marking Specialist
Job Description: We are looking for an experienced and knowledgeable Medical Software CE Marking Specialist to help our client ensure that their medical software meets all necessary safety requirements for CE marking. The software is currently registered with MHRA, UK as class-1 medical device

Responsibilities:
-Identify and assess technical requirements for CE marking of the medical software
-Support the client in preparation of all necessary documents and reports related to the CE marking process
-Ensure compliance with applicable legal and regulatory requirements
-Collaborate with the client's engineering, regulatory, and quality teams to ensure a successful CE marking process
-Provide advice and guidance on technical issues associated with CE marking

Requirements:
-Past experience in medical software CE marking
-Knowledge of European regulatory guidelines and standards for medical software
-Excellent communication, organization, and problem solving skills