Michel Spoelstra

Function For an expanding global company located in Maastricht we are searching for a Senior Regulatory Affairs Officer. You are responsible for coordinating, preparing, and maintaining regulatory documentation on a global scale for the Europe, Middle East and Asian region. You ensure regulatory compliance for assigned product line. The tasks of this position also include supporting recalls, identifying relevant standards and guidance documents that affect business and products, assisting with Governmental facility inspections, Notified Body audits, internal audits when directed and making MDR, MPR or Vigilance report recommendations.Responsibilities:Determining regional regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.Participating on various teams to define regulatory requirements of international submissions, Technical Files or regulatory rationales.Identifying guidance documents, international standards, Consensus Standards and assisting teams with their interpretation.Preparing regulatory submissions to the Notified Body and other regulatory authorities and /or Distributors.Interacting with various levels of management, external agencies and companies.Analyzing and making recommendations regarding field complaints.Developing, maintaining and analyzing department systems and providing training when needed.Remain current on developing regulations and revise systems as necessary.Participating in and assisting with Competent Authorities inspections, Notified Body Audits and other inspections and audits as directed.Assisting with supervision of department staff, as directed.Performing other related duties and tasks, as required.Requirements:Bachelor and / or Degree in biological or physical engineering or material science10 years of recent work experience.Knowledge of the Medical Devices Directive and ISO 13485 Quality System Standards.Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.Knowledge of the international regulatory environment and their regulations within the EMEA regionSelf-motivated, self-directing, strong attention to detail and excellent time management skills.Strong interpersonal and communication skillsField Action coordination and reportingProduct development and change qualification processesOffer:An exciting job at a global medical devices companyGreat remuneration packageOpportunities to grow within the companyIf you have any question about the vacancy, don’t hesitate to give Robin Bisschoff (+316.147.956.47) a call. If everything is clear you can directly apply by clicking the ‘Apply’ button. […]