Regulatory Affairs & Quality Systems Specialist

RIGICON MEDİKAL A.Ş

Company Overview:

Rigicon is exclusively focused on designing, manufacturing, and marketing innovative urology products that increase patient satisfaction. Our mission is to offer a unique and comprehensive portfolio of products and deliver high-quality solutions accessible to all customers.

Job Description:

• Assist the regulatory team in preparing regulatory documentation of CE Mark applications/surveillance,
• Preparing technical files for Class I, Class II, and Class III devices (According to2017/745 MDR),
• Following-up the QMS requirements regularly,
• Manage regulatory compliance,
• Conduct regulatory internal audits and ensure that the company is in compliance with all applicable regulations,
• Represent the company on all on-site and off-site audits,
• Stay up-to-date on regulatory changes, following-up the revision of ISO/ASTM/MDC/Meddev guidance,
• Provide regulatory advice and support to other departments, such as engineering, marketing, and sales.

Qualifications:

• Bachelor's degree in relevant fields, Master's degree is a plus,
• 4+ years of experience in Regulatory Affairs for Medical Devices,
• 4+ years of experience in Quality Management Systems,
• Excellent command of the English language, both written and verbal,
• Strong analytical and problem-solving skills,
• Proficient in Microsoft Office Suite (especially Word, Excel)
• Ability to work independently and as part of a team
• Excellent communication and interpersonal skills
• Strong attention to detail
• Ability to meet deadlines and work under pressure.

If you are experienced in medical devices regulations, eager to work in a fast-paced environment, feel confident and competent communicating in the English language please apply now!