The Senior Manager International Medical Devices, Regulatory Affairs will lead a cross-functional team to execute technical documentation in compliance with the applicable regulatory requirements and generating submissions as needed to global health authorities/notified bodies to support marketing approvals.
The primary focus of this position is to facilitate full compliance for multiple products with the Medical Device Directive (MDD) and the new European Union Medical Device Regulation (EU MDR). In this role, the individual will be the recognized expert, managing large projects or processes, with responsibilities that include working with other cross functional areas to identify, modify, or create necessary documentation to meet the EU MDD and/or remediate EU MDD compliant technical files to meet MDR. Additionally, the Sr. Manager will collaborate with global regulatory teams to ensure that the products remain compliant around the world.
Supervise direct reports: Yes
Scope of Position: Support all assigned medical device projects across several business units
Internal Business Senior Leadership
Research and Development
Manufacturing Quality Assurance
Design Quality Assurance
Global Product Surveillance and Safety
Compliance Senior Leadership (NA)
External Customers/Business Partners:
Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)