Senior Regulatory Affairs Specialist

EVMANN YÖNETİM HİZMETLERİ VE DANIŞMANLIK ANONİM ŞİRKETİ

Required Qualifications 

• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology, Pharmacy, Biomedical Engineering, or a related field.
• 5+ years of experience in Regulatory Affairs, preferably with experience inmedical device product registration and regulatory approval processes across multiple countries.
• Good knowledge of EU MDR 2017/745 and ISO 13485 requirements; knowledge ofFDA requirements is an advantage.
• Strong analytical, documentation, and communication skills.
• Fluent in English, both written and spoken.
• Willingness and ability to travel to the U.S. as required; a valid U.S. visa is preferred.

Job Description & Responsibilities

• Prepare, maintain, and keep Technical Documentation up to date in accordance withEU MDR 2017/745 and ISO 13485 requirements.
• Review Design History Files (DHF) provided by subcontractors for compliance with applicableEU MDR 2017/745 and ISO 13485 requirements, and communicate feedback and required revisions.
• Coordinate and manage audits and inspections conducted by Notified Bodies and Regulatory Authorities, overseeing all relevant Regulatory Affairs matters.
• Manage, monitor, and maintain product registrations and regulatory approvals across multiple countries, including submissions, renewals, variations, updates, and ongoing regulatory requirements.
• Manage correspondence with Notified Bodies and oversee the submission, follow-up, and approval of product changes in accordance with applicable regulatory requirements.
• Ensure that all activities within the scope of responsibility are conducted in accordance with applicablelegislation, regulations, and internal procedures.
• Ensure that product packaging materials are maintained and updated in compliance with applicable regulatory requirements and standards.
• Contribute to the development and monitoring of the Regulatory Affairs department’s annual budget, KPIs, and business plans, ensuring alignment with departmental objectives.
• Act as Deputy PRRC (Person Responsible for Regulatory Compliance), assuming the responsibilities of the PRRC in their absence and ensuring compliance withArticle 15 of EU MDR 2017/745.
• Collaborate closely with the Quality Assurance Department on regulatory, quality, and product-related matters.
• Ensure consistency between risk management, clinical data, and regulatory submissions.
• Support the preparation and maintenance of Clinical Evaluation Reports (CERs) andPost-Market Clinical Follow-up (PMCF) reports in collaboration with the Global Clinical Research Department.
• Contribute to Regulatory Affairs activities across other group companies, as required and in accordance with the direction and priorities of the manager.