Regulatory Affairs Specialist

About Us Our vision is to be a trusted scientific partner in changing the practice of prosthetic urology. We are Prosthetic Urology, we design, manufacture, and support urological prosthetic devices, including inflatable and malleable penile implants, that restore function and quality of life for patients living with erectile dysfunction and other urological conditions. We see ourselves as a genuine scientific partner to surgeons and hospital systems, not just a vendor that ships a device and disappears. We provide dedicated clinical support in the operating room, dependable product design, and a long-term commitment to advancing this field. Job Description Take part in and/or manage the regulatory approval processes of medical devices in Türkiye and global markets (EU and other target countries) Contribute to the preparation of technical documentation in compliance with MDR 2017/745 Maintain the operation of the Quality Management System in compliance with ISO 13485 , perform necessary updates, and ensure system sustainability Coordinate regulatory activities with internal departments (R&D, Quality, Clinical, Manufacturing) Manage UTS and SUT registration processes for products Participate in national and international audits, initiate and follow up CAPA actions for identified nonconformities Manage applications to and follow up processes with Notified Bodies, test laboratories, and relevant authorities Contribute to the preparation and/or review of regulatory documentation such as Clinical Evaluation Reports (CER), PMCF, and PMS-PSUR Monitor regulatory changes, inform relevant teams and management, and perform strategic assessments when necessary Provide team and process coordination in regulatory activities based on experience level Contribute to activities related to international Quality Management Systems (e.g., Brazil GMP, Korea GMP, MDSAP), if knowledgeable and experienced Qualifications Bachelor’s degree in Biomedical Engineering, Chemical Engineering, Bioengineering, or other relevant engineering or natural sciences disciplines At least 2-4 years of experience in the medical device regulatory field Well knowledge of EU MDR (2017/745) and ISO 13485