Key Skills

Job Description

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

Core Responsibilities

Prepare and maintain EU MDR technical documentation and regulatory submissions, support product registrations and lifecycle activities across EMEA, and coordinate regulatory responses and change assessments. Maintain the ISO 13485 quality system and support audits, CAPA, complaints, vigilance, supplier quality, and continuous improvement.

Requirements

Requires a bachelor’s degree or higher in a relevant scientific or technical discipline and at least five years of medical device regulatory affairs and/or quality assurance experience. Candidates need practical EU MDR and ISO 13485 experience, including Class III device registrations, and strong project management and cross-functional communication skills.