Quality & Regulatory Engineer [F/M/X]

Role: Ensure timely and accurate responses to regulatory inquiries received from global competent authorities. Collaborate with various professionals within the business unit to facilitate and develop responses to inquiries from regulators in accordance with written procedures and global requirements. Responsibilities: Coordinate with business experts to determine the information required for drafting inquiry responses. Review complaints to ensure all necessary information for inquiry responses is present and determine if further investigation is needed. Write, track, and submit inquiry responses to the necessary authorities. Monitor and improve tracking/control systems for regulatory inquiry responses. Log new inquiries into tracking tools and systems. Profile Requirements: Bachelor's degree or higher in a relevant field (biomedical engineering, science, healthcare, etc.). 4 years of experience in the medical device industry or another regulated sector. Knowledge of applicable medical device regulations and standards. Strong writing skills, attention to detail, and problem-solving abilities. Proficiency in Microsoft Office applications. Experience with complaint handling tools is a plus. What We Offer: Competitive salary and secondary benefits. Opportunity to work in a dynamic and innovative environment. Opportunities for professional development and growth within the company. Commitment to Diversity: We are proud to be an equal opportunity employer. We are committed to promoting diversity within the workforce and creating an inclusive working environment. Therefore, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Location: Eindhoven, North Brabant, NL

Posted Date: 7/31/2025