Description

In this role, you will focus on ensuring product safety by managing adverse event reporting and collaborating with various teams. Your day-to-day responsibilities will involve assessing product complaints, coordinating recalls, and maintaining compliance with regulatory standards.

Requirements

• •Bachelor’s degree or equivalent in Engineering, Science, or related field
• •0+ years of experience in medical technology, pharmaceutical industry, or regulated environment
• •Demonstrated knowledge in regulatory pathways, risk-benefit analysis, submission, registration, documentation, compliance, post-marketing surveillance, and distribution
• •Strong technical writing, coordination, execution, communication, collaboration, and autonomous decision-making skills
• •English and German language skills for global collaboration

Tasks

• •Create and submit MDRs in compliance with FDA CFR 21, part 803
• •Review and assess incoming product complaints for reportability
• •Collaborate with clinicians and Post Market Functions for reportability decisions
• •Compose rationale for events not meeting reporting criteria
• •Manage commercial holds and assess need for Recalls/FSCAs
• •Prepare and coordinate Recalls/FSCAs in line with regulatory requirements
• •Maintain communication with Marketing, Production, Sales, and other functions

Benefits