Description: Role Overview The Regulatory Affairs Sr Specialist develops and executes the regulatory submissions plans, ensuring deadlines are met and documents are properly formatted, complete, and in compliance with pharmaceutical/biologics regulatory requirements The Regulatory Affairs Manager will supervise direct reports …read more
Sales Reporting Analyst I # JN -072021-66728
1/2 time on site 1/2 time remote Description: Reporting to the Director of US Surgical Sales Analytics, the Sales Reporting Analyst is responsible for the collection, analysis, and reporting of sales related data in an on-going effort to provide …read more
EU MDR Development Engineer II # JN -072021-66580
Description: RESPONSIBILITIES INCLUDE: Assure product design history files meet the regulatory requirements of Medical Device Regulations (MDR 2017/745, internal quality system and other applicable regulations) Work to update legacy product design history file to comply with EU MDR 2017/745 focusing …read more
Regulatory Affairs Specialist IV #JN -052021-64303
Description: The Regulatory Affairs Specialist will develop and implement regulatory strategies, focused on Orthopedic products and on achieving compliance with the upcoming European Medical Device Regulation. The Regulatory Affairs Specialist will be responsible for providing regulatory input and strategic direction …read more
Complaints Investigator # JN -012020-51012
Description: This is a Complaints Investigator position for IGT Devices; part of the Image Guided Therapy business group. In this role, you have the opportunity to work with cutting-edge medical device product lines Responsible for any of the following: Day-to-day …read more
Software Validation Engineer # JN -012020-51024
Description: The Software Validation Engineer role will work closely with the Software Validation Management Team, other Q&R personnel and various project teams throughout the organization and across multiple sites. In this role, you will help provide regulatory guidance and perform …read more
Post Market Surveillance Consultant # JN -012020-51013
Description: Handle the receipt, processing, monitoring, and reporting of product defect complaints, Make MDR determination, investigate document the all activities creating the summaries of the investigation. Documented product complaints into the database for trending and analysis and ensured the complaint …read more
