EMEA Compliance & Regulatory Specialist - Medical Devices Industry

only CVs in English will be reviewed and considered for the recruitment process.

Angel Aligner is a global service provider of clear aligner technology, production, and sales. Since founded in 2003, we have been working on developing high-tech products to bring beautiful smiles and confidence to people around the world. Over the past 20 years we have maintained a productive corporate-academic partnership with many different orthodontists and universities around the world, and our R&D team has made tremendous breakthroughs in many fields, to ensure that Angel Aligner is at the cutting edge of technology and product development. Over 150 patents have been obtained in respect of processing, clear aligners, manufacturing, and 3D printing technology. Be part of a fast‑moving, mission-driven healthcare company improving patient outcomes. Competitive compensation and opportunities for career development. Compliance & Regulatory Lead This role is critical to ensure that our operations across EMEA meet the highest regulatory and compliance standards within the medical device industry. This is an exciting opportunity for a proactive, detail‑oriented, and collaborative compliance professional who thrives in an international environment and is comfortable managing regulatory interactions across multiple regions. Regulatory & Compliance Leadership (Europe, Middle-East, Africa & India) Serve as the primary point of contact for compliance and regulatory topics between the EMEAI region and headquarters in China. Ensure that all operational, commercial, and communication activities in EMEAI comply fully with EU MDR and other applicable regulations. Take ownership of local declarations and product/activity registrations across Europe, ensuring timely updates and ongoing compliance with national regulatory bodies. Lead regulatory planning and support new country launches, ensuring efficient registration and market entry. Assist field teams by responding to customer questions, regulatory objections, or compliance concerns related to medical devices. Develop and deliver internal training sessions on MDR, regulatory expectations, and compliance procedures. Collaborate with Quality, Marketing, Sales, Clinical, and Operations teams to ensure alignment on regulatory topics. Project Management Lead and execute EMEAI-wide projects focused on regulatory or compliance improvements. Contribute to internal audits, risk assessments, and continuous compliance improvement initiatives. Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field. Proven experience in medical devices within a regulatory, compliance, or quality function. Experience handling local declarations and regulatory registrations in European countries. Experience working in cross-cultural, international environments—experience collaborating with APAC teams is a plus. Fluent English (spoken & written); Strong organizational and project management abilities.