Senior Quality Assurance & Regulatory Affairs Specialist

EVMANN YÖNETİM HİZMETLERİ VE DANIŞMANLIK ANONİM ŞİRKETİ

General Qualifications and Job Description

Streliza Corp., an EVMANN Holding company, is seeking a Senior Quality Assurance & Regulatory Affairs Specialist who will be responsible for managing both Quality Assurance and Regulatory Affairs processes.

The successful candidate will be responsible for maintaining and continuously improving the Quality Management System (QMS), ensuring product compliance with quality standards and applicable regulatory requirements, managing technical documentation, and coordinating international product registration and approval processes.

General Qualifications

• Bachelor’s degree in Biomedical Engineering, Chemical Engineering, Chemistry, Biology, Pharmacy, or a related field.
• At least 5 years of experience in Quality Assurance and/or Regulatory Affairs, preferably in the medical device industry.
• Hands-on experience in both Quality Management Systems and Regulatory Affairs processes.
• Solid knowledge of ISO 13485 and EU MDR 2017/745 requirements.
• Knowledge of ISO 14971, ISO/TR 24971, MDSAP, and FDA requirements is preferred.
• Experience in technical file preparation and maintenance, product registration, regulatory submissions, and audit processes.
• Knowledge of CAPA, nonconformity management, root cause analysis, and risk management.
• Proficiency in written and spoken English.
• Strong analytical thinking, planning, organizational, and problem-solving skills.
• Excellent attention to detail and strong documentation management skills.
• Ability to work collaboratively with cross-functional teams and independently manage processes.
• Willingness and ability to travel internationally when required.
• A valid U.S. visa is preferred.

Job Description

• Maintain, implement, and continuously improve the Quality Management System (QMS) in accordance with ISO 13485 and applicable regulatory requirements.
• Manage the preparation, review, and revision of quality procedures, work instructions, and records.
• Coordinate CAPA, nonconformity management, deviation handling, change control, root cause analysis, and risk management processes.
• Plan and coordinate internal and external audits and follow up on audit findings through to closure.
• Prepare, review, and maintain technical documentation in compliance with EU MDR 2017/745 and applicable standards.
• Manage product registration, regulatory submissions, licensing, renewals, and change notification processes across different countries.
• Coordinate correspondence and submission processes with Notified Bodies and regulatory authorities.
• Review technical documentation prepared by subcontractors and coordinate any necessary revisions.
• Ensure that product labeling and packaging materials comply with applicable regulatory requirements.
• Contribute to the preparation and maintenance of Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) documentation, and post-market surveillance documentation.
• Ensure consistency between product compliance, quality risks, and technical documentation.
• Monitor and report quality performance indicators (KPIs) and drive continuous improvement initiatives.
• Collaborate with relevant departments and group companies on Quality Assurance and Regulatory Affairs activities.
• Perform the duties of a Person Responsible for Regulatory Compliance (PRRC) or Deputy PRRC, subject to meeting the applicable regulatory qualification requirements and completion of the necessary formal appointments.