RAQA Specialist / Senior Specialist EMEA

Position Summary

We are seeking an experienced and hands-on Regulatory Affairs & Quality Assurance (RAQA) Specialist / Senior Specialist to support our medical device business across the EMEA region, with a strong focus on regulatory submissions, EU MDR compliance, regional regulatory activities, and Quality Management System maintenance.

Key Responsibilities

1. Regulatory Affairs

· Prepare, compile, review and maintain EU MDR technical documentation and regulatory submission dossiers for medical devices.

· Support new product registrations, renewals, regulatory changes and lifecycle management activities across Europe and other EMEA markets, including Russia, Kazakhstan and Egypt.

· Support interactions and submissions with EU Notified Bodies, Competent Authorities and other regulatory authorities within the EMEA region.

· Assess the regulatory impact of product, design, manufacturing, supplier and labeling changes and coordinate required regulatory actions.

· Monitor relevant regulatory requirements, standards and guidance and translate regulatory changes into actionable requirements.

· Work closely with R&D, Clinical, Quality and other cross-functional teams to ensure timely delivery of regulatory projects.

· Provide regulatory documentation and technical support for reimbursement, tender, market access and other local regulatory-related requirements in EMEA markets.

· Support distributors and local partners with regulatory documentation required for product registration and market access.

2. Quality Assurance

· Maintain and support the ISO 13485 Quality Management System and ensure continued compliance with applicable requirements.

· Maintain QMS procedures, records and quality documentation and support alignment with the corporate Quality Management System.

· Support internal and external audits and coordinate follow-up actions and CAPA where required.

· Support key quality processes including document control, training, change control, CAPA, complaint handling and supplier/distributor quality management.

· Support post-market quality and regulatory activities, including complaints, vigilance reporting, field safety corrective actions and regulatory reporting, as applicable.

· Support management review, quality objectives, quality metrics and continuous improvement activities.

Qualifications & Competencies

· Bachelor’s degree or above in Life Sciences, Biomedical Engineering, Engineering, Pharmacy or a related scientific or technical discipline.

· 5+ years of Regulatory Affairs and/or Quality Assurance experience in the medical device industry.

· Strong knowledge and practical experience with EU MDR and medical device technical documentation, with the ability to independently prepare and review regulatory documents.

· Solid knowledge of ISO 13485 and practical experience in maintaining or supporting a certified Quality Management System.

· Experience working with EU Notified Bodies and responding to regulatory or technical documentation review questions.

· Demonstrated experience in registering Class III high-risk medical devices is required; experience in neurovascular, cardiovascular, interventional or implantable devices is an advantage.

· Strong project management, communication and cross-functional collaboration skills, with the ability to manage multiple projects effectively.

· Ability to work effectively in an international and cross-cultural environment.

· Chinese languages skills are desirable but not essential

· This role will be home based but will require the candidate to travel to group offices in Netherlands and / or UK. Candidates should ideally be based in Netherlands

· This role will require occasional international travel