Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and driving the transition to the Medical Device Regulation (MDR).The ideal candidate will have a minimum of 3-5 years of experience in the medical device industry, with a strong understanding of EU Medical Device Directive and relevant guidelines. They will also have practical knowledge of ISO 13485, ISO 14001, and ISO 45001.The role requires excellent communication and interpersonal skills, with the ability to interface with different cultures and external bodies. The candidate must also be process-oriented, analytical, and able to manage policies, procedures, and databases.We offer a challenging and rewarding role in a growing international company, with opportunities for career development and growth. Our benefits package includes competitive salary, flexible working hours, company pension scheme, and many more.If you are a motivated and organized individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.About the Job:Key Responsibilities:Ensure compliance with regulatory requirements, including CE marking and registration documents.Drive the transition to MDR and ensure that all mandatory legal information is available when needed.Interface with Sales, Marketing, and QA Departments to ensure PMS activities are conducted under regulatory supervision.Required Skills and Qualifications:Minimum 3-5 years of experience in the medical device industry.Strong understanding of EU Medical Device Directive and relevant guidelines.Practical knowledge of ISO 13485, ISO 14001, and ISO 45001.Excellent communication and interpersonal skills.Process-oriented, analytical, and able to manage policies, procedures, and databases.Benefits:Competitive salary.Flexible working hours.Company pension scheme.Others:Opportunities for career development and growth.A dynamic and multicultural work environment.