Requirements: English
Company: Technomed Engineering BV
Region: Kerkrade , Limburg
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.
The primary work location is Kerkrade, Netherlands.
Your responsibilities are - Lead the execution of global regulatory strategies for new and existing products;
- Serve as the regulatory lead for business-critical projects, influencing product development, lifecycle management, and market entry;
- Oversee global regulatory submissions and ensure accurate technical documentation;
- Manage product changes, labeling updates, and post-market surveillance and support risk assessments;
- Partner with Quality Assurance to ensure alignment of regulatory and quality systems;
- Lead or support internal and external audits, inspections, and corrective actions;
- 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;
- Ensure continuous improvement and operational excellence.
What you bring to the role As a Manager Regulatory Affairs, you have expert knowledge of global regulatory frameworks. You possess strong leadership and project management skills and thrive in a fast-paced environment. With a strategic mindset and excellent communication skills, you collaborate effectively across functional areas. You also have:
- 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;
- Proven expertise with global regulatory submissions;
- A strong track record in managing regulatory audits and inspections;
- Regulatory Affairs Certification (RAC), strongly preferred.
What you can expectYou 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. Additionally, you will enjoy a pleasant, collegial, and challenging atmosphere where independence and self-initiative are highly valued.
Who are weYou will be part of the growing and ambitious environment of the Welcony group. We believe that technology can have a major impact on patients'' lives.
Welcony is a leading healthcare technology company that unites four distinguished brands: Magstim, MagstimEGI, Technomed, and Neurosign. Together, we offer a comprehensive range of innovative solutions, including Transcranial Magnetic Stimulation (TMS), Electroencephalography (EEG), Neuromonitoring, and Clinical Neurophysiology products. Our combined expertise and advanced technologies are dedicated to enhancing patient outcomes and supporting healthcare professionals across the globe.
How to apply for this career opportunity?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. Website:
Go to websiteTrefwoorden: Vacancy, Master''s degree, Bachelor''s degree, Manager Regulatory affairs, Limburg, Kerkrade
Acquisition to this vacancy is not appreciated.
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