Warsaw, IN · On-site
$76 - $88/hr
Review test case execution results and manage software defects * Facilitate software risk ... 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA) * Collaborate closely with R&D and cross ...
Warsaw, IN · On-site
$76 - $88/hr
Review test case execution results and manage software defects * Facilitate software risk ... 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA) * Collaborate closely with R&D and cross ...
... risk management, and continuous improvement activities. * Working knowledge of ISO 9001 & ISO 13485 standards, and 21 CFR Part 820 & EU MDR/IVDR regulations * Bachelor's Degree (minimum) in ...
... risk management, and continuous improvement activities. * Working knowledge of ISO 9001 & ISO 13485 standards, and 21 CFR Part 820 & EU MDR/IVDR regulations * Bachelor's Degree (minimum) in ...
Indianapolis, IN · On-site
$68K - $88K/yr
ISO 9000/9001, ISO 13485, 21 CFR, and EU MDR especially pertaining to quality management systems, good manufacturing practices, medical devices, and auditing. * Vision requirements for this position:
Indianapolis, IN · On-site
$68K - $88K/yr
ISO 9000/9001, ISO 13485, 21 CFR, and EU MDR especially pertaining to quality management systems, good manufacturing practices, medical devices, and auditing. * Vision requirements for this position:
... risk management, and continuous improvement activities. * Working knowledge of ISO 9001 & ISO 13485 standards, and 21 CFR Part 820 & EU MDR/IVDR regulations * Bachelor's Degree (minimum) in ...
... risk management, and continuous improvement activities. * Working knowledge of ISO 9001 & ISO 13485 standards, and 21 CFR Part 820 & EU MDR/IVDR regulations * Bachelor's Degree (minimum) in ...
... Quality Management System (QMS). The Design Quality Engineer will be responsible to ensure that ... and the EU Medical Device Regulations (MDR). * Supports, reviews, and approves the following ...
... Quality Management System (QMS). The Design Quality Engineer will be responsible to ensure that ... and the EU Medical Device Regulations (MDR). * Supports, reviews, and approves the following ...
... UK MDR 2012 schemes. * Manage certification activities for a portfolio of medical device ... Familiarity with the Medical Devices Regulation (EU)2017/745 and/ or Medical Devices Directive 96 ...
... UK MDR 2012 schemes. * Manage certification activities for a portfolio of medical device ... Familiarity with the Medical Devices Regulation (EU)2017/745 and/ or Medical Devices Directive 96 ...
... UK MDR 2012 schemes. * Manage certification activities for a portfolio of medical device ... Familiarity with the Medical Devices Regulation (EU)2017/745 and/ or Medical Devices Directive 96 ...
... UK MDR 2012 schemes. * Manage certification activities for a portfolio of medical device ... Familiarity with the Medical Devices Regulation (EU)2017/745 and/ or Medical Devices Directive 96 ...
| Aspect | Manager Eu Mdr | Regulatory Affairs Specialist |
|---|---|---|
| Credentials | Typically requires advanced degrees and experience in medical devices and EU regulations | Usually holds a degree in life sciences or regulatory affairs, with certifications in regulatory processes |
| Work Environment | Leads teams, manages compliance projects, and interacts with multiple departments | Focuses on preparing documentation, ensuring regulatory submissions, and supporting compliance tasks |
| Industry Usage | Commonly used in medical device companies within the EU | Found across medical device, pharmaceutical, and biotech industries |
| Search & Comparison Intent | Often compared for roles with managerial responsibilities in EU MDR compliance | Compared for specialized regulatory roles supporting EU MDR adherence |
The Manager Eu Mdr oversees compliance teams and strategic implementation of EU MDR regulations, while the Regulatory Affairs Specialist handles documentation and submission tasks. Both roles require regulatory knowledge, but the manager has broader leadership responsibilities.
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