Regulatory Affairs Specialist
This is a full-time role for a Regulatory Affairs Specialist. As a key member of our team, you will lead the development and implementation of process automation in Quality Management Systems (QMS).
Key Responsibilities:
* Support the design and validation of automated regulatory and quality processes for medical devices.
* Ensure regulatory compliance with applicable legislation, standards, and guidance throughout the automation and software development lifecycle.
* Act as a liaison between regulatory experts and software/AI development teams to align functional requirements with regulatory expectations.
* Review AI/ML models and automation tools from a regulatory perspective to ensure traceability, transparency, and compliance.
* Monitor evolving regulatory trends related to software and AI in medical devices and contribute to internal best practices.
Academic Qualifications:
* Minimum Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field.
Specific Knowledge/Training:
* Training in ISO 13485, ISO 14971, and IEC 62304.
Professional Experience:
* 4+ years of experience in regulatory affairs or quality of medical devices.
Skills Profile:
* Up-to-date knowledge of medical device regulations, standards, and guidance (EU MDR, FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDCG guidance).
* Practical experience in regulatory areas such as risk management, clinical evaluation, literature search, and post-market surveillance (PMS).
* Hands-on experience with regulatory strategy and documentation for Medical Device Software (MDSW), including IEC 62304.
* Familiarity with regulatory challenges and validation of AI/ML-based MDSW.
* Experience working with eQMS systems and/or regulatory process automation tools.
* Strong technical writing and documentation skills.
* Proficient oral and written communication skills for collaboration with IT, regulatory, and external stakeholders.
Benefits:
* Competitive annual base salary.
* Performance-based bonus and flexible work arrangements/benefits.
* Professional development and certification support.
* Training and continuous skills development.
* Impactful and innovative projects for the healthcare sector.