Regulatory Affairs and Quality Assurance Vice President - Mechelen - Nipro Europe Group
The Vice President of Regulatory Affairs, Clinical Affairs, and Quality Assurance will lead the RA/QA/CA team within Nipro Medical Europe, ensuring compliance with quality and regulatory requirements for medical devices.
This role is responsible for ensuring that NME and its manufacturing facilities meet obligations described in the Medical Devices Regulations, including regulatory compliance, vigilance, post-market surveillance, and clinical evaluation.
The successful candidate will also be responsible for product registrations according to applicable country/market requirements within the NME territory.
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.
* Ability to create and lead a strategy.
* International experience.
Estimated Salary: €120,000 - €150,000 per year
#J-18808-Ljbffr