Regulatory Affairs Specialist

Rigicon® Innovative Urological Solutions; Bakırköy; On-site; TRY 300,000 - 460,000; Full time

Job summary

Rigicon® Innovative Urological Solutions in Turkey seeks a regulatory affairs professional to guide medical device approvals across Türkiye and international markets. You will help maintain MDR compliance and ISO 13485, coordinating with R&D, Quality, Clinical and Manufacturing teams to keep projects on track.

The role covers registration with Notified Bodies, CER/PMCF reviews, audits, CAPA follow-ups, and monitoring regulatory changes to inform management and shape strategic decisions.

Qualifications

• Bachelor's degree in Biomedical Engineering, Chemical Engineering, Bioengineering, or related field.
• 2–4 years of experience in medical device regulatory affairs.
• Strong knowledge of EU MDR (2017/745) and ISO 13485.

Responsibilities

• Take part in regulatory approval processes for Türkiye and global markets.
• Prepare technical documentation per MDR 2017/745.
• Maintain QMS in ISO 13485 compliance and updates.
• Coordinate regulatory activities with R&D, Quality, Clinical, Manufacturing.
• Manage UTS and SUT registration processes for products.
• Participate in audits and CAPA actions for nonconformities.
• Manage applications with Notified Bodies, test labs, authorities.
• Contribute to CER, PMCF, and PMS-PSUR reviews.
• Monitor regulatory changes and advise management.
• Provide team coordination in regulatory activities.
• Contribute to international QMS activities (Brazil/Korea MDSAP).

Skills

Regulatory affairs

EU MDR knowledge

ISO 13485 knowledge

Cross-functional coordination

Audits participation

Education

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Chemical Engineering

Bachelor's degree in Bioengineering

Job description

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