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Regulatory Affairs and Quality Assurance Vice President - Mechelen - Nipro Europe Group
Functie: Regulatory Affairs and Quality Assurance Vice President
Regulatory Affairs and Quality Assurance Leadership
The Vice President of Regulatory Affairs, Clinical Affairs, and Quality Assurance will oversee the RA/QA/CA team within Nipro Medical Europe, ensuring compliance with quality and regulatory requirements for medical devices.
Key Responsibilities:
* Develop and implement regulatory affairs processes to ensure compliance with current country regulations and requirements.
* Ensure processes are developed to ensure compliance with environmental requirements for the distribution and import of medical devices.
* Integrate regulatory and clinical planning with other functional leaders to plan for new or modified products or processes.
* Coordinate with other functional leaders to review and agree registration timelines and resource requirements.
* Ensure that regulatory and environmental non-compliance is communicated to NME Management Team.
* Act as the PRRC to verify regulatory compliance of medical devices where NME is Authorized Representative.
* Manage, guide, and coach the RA Team to create and/or maintain compliance to applicable regulatory requirements.
* Accountable for incident reporting to Competent Authorities.
* Ensure the team meets regulatory requirements related to timely reporting, accurate, and comprehensive medical device reporting and follow-up.
* Manage, guide, and coach the Complaint and PMS Team.
* Develop a clinical strategy, plan, and manage Nipro Medical Europe Clinical Studies in collaboration with NME Marketing Team and Global Product Development Team.
* Ensure Clinical Evaluation processes are in accordance with applicable regulation and internal procedures.
* Act as Management Representative for NME in accordance with ISO 13485:2016.
* Ensure processes needed for Quality Management System are established, implemented, and maintained.
Requirements:
* University degree in a scientific field or equivalent by experience.
* Strong experience in RA and QA departments within the Medical Devices sector.
* Experience with MDRs.
* Excellent people management skills, able to lead managers.
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