Quality Management & Regulatory Specialist - MEDICAL DEVICES Porto

Quality Management & Regulatory Specialist - MEDICAL DEVICES
Porto
Porto, Porto District, Portugal

Company Description

CRITICAL CATALYST is a specialized consulting company in Regulatory Affairs and Public Health. We provide expert guidance in Medical Devices ensuring businesses meet all applicable legal requirements and international standards. Our mission is to create clear paths through regulatory complexity. Our projects span the European Union, United Kingdom, United States, Gulf Region and ASEAN countries. We foster
- management and cooperation while respecting individual identities, beliefs and ideas. We prioritize employee growth and development in a positive work environment.

Role Description

This is a
- time role for a Quality Management & Regulatory Specialist at CRITICAL CATALYST. As Quality Management Specialist you will lead the development and implementation of process automation in Quality Management Systems (QMS). As a Regulatory Specialist you will be responsible for developing, improving and implementing regulatory standards for manufacturing operations of Medical Devices. The role is based in Matosinhos - Porto, with flexibility for remote work.

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 Masters 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
- 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 e
QMS 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 of 30, 000 to 45, 000 EUR based on experience

- 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