Ergreife deine Chance als Vigilance Manager (f/m/d) bei Olympus Europa SE & Co KG – Arbeitsort Hamburg
Olympus Europa SE & Co. KG
Hamburg
Stellenausschreibung
Your responsibilities
Ensure compliance with the reporting obligations for medical devices to the Competent Authorities according to the different countries/regulations (e. g. Regulation (EU) 2017/745 “Medical Device Regulation (MDR)”, US FDA Regulation 21 CFR Part 803 “Medical Device Reporting”, UK Medical Device Regulations)
Collect notifications regarding complaints on medical devices, takes (reportability) decisions and coordinates appropriate actions
Coordinate timely response to information requests from Competent Authorities
Notify non-Olympus legal manufacturers about potential safety-relevant complaints received from the market for further assessment and gather additional information upon request
Develop process improvements in alignment with upcoming new internal and external requirements
Explain reportability decisions during audit situations (for example during FDA, Notified Body and MDSAP audits)
Provide reports of ongoing activities to the management upon request
Participate in other ad-hoc duties / projects as required
Your qualification
Successful completion of a Bachelor's or Master's degree in engineering or equivalent professional or technical qualification (skills acquired through relevant practical experience)
Very good communication skills and command of the English language (verbal and in writing)
Good analytical understanding
Ability to work in a team and demonstrated flexibility