Etienne Crombach is a seasoned Freelance Regulatory Affairs (RA) and Quality Assurance (QA) Professional at Crombach Consultancy, where he leverages his extensive expertise to navigate the complex regulatory landscape of the medical device and pharmaceutical industries. With a strong focus on strategic business planning and...
Etienne Crombach is a seasoned Freelance Regulatory Affairs (RA) and Quality Assurance (QA) Professional at Crombach Consultancy, where he leverages his extensive expertise to navigate the complex regulatory landscape of the medical device and pharmaceutical industries. With a strong focus on strategic business planning and product lifecycle management, Etienne plays a pivotal role in ensuring that engineering and manufacturing operations comply with stringent regulatory requirements. His proficiency in supplier qualification, internal and due diligence audits, and remediation strategies positions him as a trusted advisor for organizations seeking to enhance their compliance frameworks.
Currently, Etienne is spearheading several key projects that involve the development of comprehensive registration and marketing strategies for medical devices across various global markets. His ability to liaise effectively with Competent Authorities and regulatory agencies has been instrumental in securing and maintaining market access for his clients. By composing detailed product technical dossiers in accordance with the STED format, he ensures that all submissions meet the rigorous standards set forth by regulatory bodies.
Fluent in Dutch, English, and German, Etienne excels in communication, employing his diplomatic and mediation skills to foster collaborative relationships with stakeholders. His analytical and abstracting skills enable him to dissect complex regulatory requirements and translate them into actionable strategies. With a solid foundation in GxPs, ISO 13485, MDD 93/42/EEC, CE marking, PMA, 510(k), and QSIT inspections, Etienne is well-equipped to guide organizations through the intricacies of quality systems, validation, and CAPA processes. His commitment to corporate governance and quality assurance ensures that his clients not only meet compliance standards but also achieve operational excellence in the life sciences sector.
