Qualifications

Education:

Bachelor's degree in Biology, Molecular Biology and Genetics, Chemistry or, Bioengineering, or a related field. Advanced degree preferred.

Experience:

Minimum of 3-5 years of experience in Regulatory Affairs, preferably within the IVD or medical device industry.
Experience in regulatory project management and a strong understanding of regulatory requirements for IVD products.

Skills and Competencies:

Thorough knowledge of global regulatory requirements, including EU IVDR, FDA, ANVISA regulations, and local requirements (e.g., TİTCK).
Strong project management skills, including the ability to manage multiple projects and deadlines.
Excellent written and verbal communication skills in both Turkish and English.
Detail-oriented with strong analytical and problem-solving abilities.
Proficiency in using regulatory databases and project management tools.
Ability to work independently and as part of a team.

Key Responsibilities

Regulatory Affairs (70%):

Regulatory Submissions and Documentation:

Prepare, review, and submit regulatory documentation for new product registrations, renewals, and amendments in accordance with global and local regulations (e.g., TİTCK, EU IVDR, FDA, ANVISA).
Maintain up-to-date knowledge of regulatory requirements and ensure that all documentation is compliant.
Compliance and Risk Management:
Ensure products comply with relevant regulatory standards and guidelines throughout their lifecycle.
Conduct risk assessments and implement mitigation strategies as part of the regulatory compliance process.

Regulatory Intelligence:

Support monitoring and interpretation regulatory changes and trends that could impact the company's IVD products.
Provide executive summaries for communication of regulatory updates and their implications to relevant internal stakeholders.

Quality Management System (QMS):

Collaborate with the Quality Assurance team to ensure the QMS meets regulatory requirements (e.g., ISO 13485:2016).
Support internal and external audits related to regulatory compliance.

Labeling and Marketing Materials:

Provide support on review and approval of labeling, packaging, and promotional materials to ensure compliance with regulatory standards.
Provide regulatory guidance on claims and advertising strategies.

Regulatory Project Management (30%):

Project Coordination:

Lead and manage regulatory projects from initiation to completion, ensuring timely delivery of regulatory milestones.
Develop and maintain project plans, timelines, and status reports.

Cross-functional Collaboration:

Work closely with cross-functional teams, including R&D, Quality, Marketing, and Sales, to ensure regulatory requirements are integrated into product development and commercialization processes.
Facilitate communication and coordination between departments to ensure project objectives are met.

Resource Management:

Documentation and Reporting:

Maintain accurate and organized project documentation.
Prepare and present project status updates, reports, and regulatory findings to management and stakeholders.

Istanbul, TR

Regular Full-Time