Technomed Engineering BV
jobid=A.0.0497
Your role as Manager Regulatory Affairs As a Manager Regulatory Affairs, you will take the lead in shaping and executing regulatory strategies to ensure global compliance for Welcony’s portfolio. In this role, you will not only provide expert guidance and strategic oversight but also serve as a key liaison between regulatory authorities and senior management. Leading a team of regulatory professionals, you will drive regulatory initiatives and cross-functional collaboration to support Welcony’s products in meeting global requirements. This is a hybrid position, with the primary work location in Kerkrade, Netherlands. Serve as the regulatory lead for business-critical projects, influencing product development, lifecycle management, and market entry; Manage product changes, labeling updates, and post-market surveillance and support risk assessments; Partner withQuality Assurance to ensure alignment of regulatory and quality systems; Coach and lead the Regulatory Affairs team and ensure business objectives are met; Represent Regulatory Affairs in cross-functional teams to provide regulatory guidance to projects, including clinical studies, product development, and market strategies; Actively participate in strategic planning and product launch readiness; As a ManagerRegulatory Affairs, you have expert knowledge of global regulatory frameworks. You possess strong leadership and project management skills and thrive in a fast-paced environment. A Bachelor’s / Master’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field; ~8-10 years of experience in Regulatory Affairs in a medical device company; ~ A strong track record in managing regulatory audits and inspections; ~ RegulatoryAffairs Certification (RAC), strongly preferred. You will be part of a vibrant, global team within a fast-growing Medical Device company that encourages an open and informal culture. Our enthusiastic team values short lines of communication, responsibility, and a strong focus on results. In this inspiring work environment, you can expect a competitive salary that aligns with your experience and skills, along with great benefits and a variety of opportunities for training and further education. We believe that technology can have a major impact on patients’ lives. Welcony is a leading healthcare technology company that unites four distinguished brands: We appreciate hearing from all qualified candidates by submitting your application by using our Online Application Form. For questions and more information about the Manager Regulatory Affairs vacancy, please contact Karen Eberson (HR Manager) on phone number 0434086878. Vacancy, Master’s degree, Bachelor’s degree, Manager Regulatory affairs, Limburg, Kerkrade Acquisition to this vacancy is not appreciated. Your role as Manager Regulatory Affairs As a Manager Regulatory Affairs, you will take the lead in shaping and executing regulatory strategies to ensure global compliance for Welcony’s portfolio. In this role, you will not only provide expert guidance and strategic oversight but also serve as a key liaison between regulatory authorities and senior management. Leading a team of regulatory professionals, you will drive regulatory initiatives and cross-functional collaboration to support Welcony’s products in meeting global requirements. This is a hybrid position, with the primary work location in Kerkrade, Netherlands. Serve as the regulatory lead for business-critical projects, influencing product development, lifecycle management, and market entry; Manage product changes, labeling updates, and post-market surveillance and support risk assessments; Partner withQuality Assurance to ensure alignment of regulatory and quality systems; Coach and lead the Regulatory Affairs team and ensure business objectives are met; Represent Regulatory Affairs in cross-functional teams to provide regulatory guidance to projects, including clinical studies, product development, and market strategies; Actively participate in strategic planning and product launch readiness; As a ManagerRegulatory Affairs, you have expert knowledge of global regulatory frameworks. You possess strong leadership and project management skills and thrive in a fast-paced environment. A Bachelor’s / Master’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field; ~8-10 years of experience in Regulatory Affairs in a medical device company; ~ A strong track record in managing regulatory audits and inspections; ~ RegulatoryAffairs Certification (RAC), strongly preferred. You will be part of a vibrant, global team within a fast-growing Medical Device company that encourages an open and informal culture. Our enthusiastic team values short lines of communication, responsibility, and a strong focus on results. In this inspiring work environment, you can expect a competitive salary that aligns with your experience and skills, along with great benefits and a variety of opportunities for training and further education. We believe that technology can have a major impact on patients’ lives. Welcony is a leading healthcare technology company that unites four distinguished brands: We appreciate hearing from all qualified candidates by submitting your application by using our Online Application Form. For questions and more information about the Manager Regulatory Affairs vacancy, please contact Karen Eberson (HR Manager) on phone number 0434086878. Vacancy, Master’s degree, Bachelor’s degree, Manager Regulatory affairs, Limburg, Kerkrade Acquisition to this vacancy is not appreciated.
