Regulatory Technical Reviewer - Healthcare(m/w/x)

Description

As a Healthcare Regulatory Technical Reviewer, you will focus on ensuring product compliance with regulatory standards while managing certification projects. Your role involves evaluating clinical performance, improving assessment protocols, and collaborating with the Commercial team to estimate clinical assessments.

Requirements

• •Bachelor’s degree in technical, medical, or scientific studies or comparable professional knowledge
• •5+ years of relevant experience in management system certification in medical devices
• •Profound knowledge of regulations for certification of MD/IVD devices
• •Profound knowledge of global medical device conformity assessment programs
• •Multiple years of experience in evaluation and decision making for medical devices
• •Qualification as management system auditor in healthcare sector
• •Strong interpersonal skills, self-starter, good decision-making and organizational skills
• •Technical competence to evaluate all products with assistance
• •Ability to manage multiple assessments and changing schedules
• •Demonstrates technical competence to review work of others
• •Demonstrates technical competence in two or more technical scopes
• •Excellent communication skills (verbal and written)
• •Strong conflict resolution skills
• •Good command in German and English; any other European language is a benefit
• •Ability to travel as needed with short notice (up to 15% travel)

Tasks

• •Ensure assessments address regulatory responsibilities
• •Formulate and improve assessment procedures
• •Independently manage certification projects
• •Evaluate products against national and international standards
• •Support the Commercial team with clinical assessment estimates
• •Deliver projects within agreed timescales
• •Review test data and reports
• •Participate in assessments

Benefits