Location: Tarrytown, NY 10591
Duration: 6+ Months
We are looking for 1 candidate to support a major regulatory effort called IVDR. As part of the tasks , the candidates will be asked to find supporting information in existing Siemens databases and via literature search to support different aspects of our product (i.e. evidence of clinical study data, publication listing , etc.). The candidate will be asked to compile all that information in different reports and format. Therefore, ability to conduct all sort of information search independently with internal and external tools is a must.
The ideal candidate would have IVDR experience, have been involved in regulatory submission and clinical studies.
Specifically, the selected candidates will also be asked to
• Keep project manager aware of progress of all deliverables
• Capture gaps, and manage activities
Clearly gather information and generate respective reports.
Communicate issues timely and find mitigation
• Manage her/his files; notify RA when each file is complete
• B.A./B.S. (med tech, biology or equivalent); typically 5-10 years experience in the field, preferably in regulatory or clinical areas.
• Strong IVDR and / or MDR understanding and working knowledge
Strong writing skills. Having authored scientific publications is a nice to have.
• Experience with global registrations of in vitro diagnostic devices or medical devices
• Strong technical background, preferably in the in vitro diagnostics or medical device industry
• Strong interpersonal, communication and organizational skills required
• Must be able to set priorities as well as adapt to changing priorities
• Ability to function in a changing, high-impact position, with deadline and resource constraints