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Michel Spoelstra

About Michel Spoelstra

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So far Michel Spoelstra has created 3 blog entries.

Senior Regulatory Affairs Officer – Maastricht

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. […]
By |October 30th, 2018|Compliance, Regulatory Affairs, Vacancies|0 Comments

Quality Assurance Manager – Liège

Function The Quality Assurance Manager for one of our clients in Belgium is responsible for ensuring that all managers & process owners develop and maintain their part of the quality management system, in addition to supporting the development and maintenance of a customer-focused culture.Responsibilities:Ensuring the product is labelled and packed to current specifications and distributed in a way that meets regulatory requirementsBeing responsible for the continuous development of processes and systems to facilitate the attainment of a World Class Organization.Being responsible for the continuous development, monitoring and implementation of the Quality Management System including key Quality Processes such as CAPA, NCR and Change Management, etc. Follow Good Manufacturing Practices (GMP) ensuring compliance with current regulations.Working with the Management Team to meet all site performance indicators, including Service Level Conformance (analysis & reporting of data).Managing the day-to-day activities of the QA Team.Requirements:Bachelor’s DegreeMinimum 2 years experience in the capacity of QA ManagerExperience with People ManagementExperience in a Regulated IndustryExperience with Change ManagementExperience with QMS ManagementExperience in a matrix organizational environmentKnowledge of English and French languageYou can contact Michelle Wegter if you have any questions regarding this position on +31 43 321 71 71.You can apply by clicking the ‘Apply’ button […]
By |September 27th, 2018|Vacancies|0 Comments

Regulatory Affairs Officer – Limburg

Function For one of our clients we are searching for a Regulatory Affairs Officer.Responsibilities:Writing scientific texts for new productsCompliance activities including checking and correctly interpreting regulations, submitting regulatory affairs, supervising variations and submitting requests for registration transfers of dossier updatesOperating on renewals independentlyAssisting with the compilation and completion of registration dossiersCollecting all kinds of administrative documents (permits, GMP certificates, samples, etc.) from internal and external parties answering questions from authorities during national registration procedures for self-prepared registration dossiersLiaising and communicating with different departmentsMaintaining internal procedures and internal administration […]
By |April 5th, 2018|Compliance, Regulatory Affairs, Vacancies|0 Comments