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EMEA Compliance & Regulatory Specialist - Medical Devices Industry

hace 3 días

Madrid

IMPORTANT : only CVs in English will be reviewed and considered for the recruitment process. Who We Are: 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. Why Angel Aligner? With over one million patients treated and over two decades of innovation, we’re not just transforming smiles—we’re aiming to shape the future of clear aligner therapy. At Angel Aligner, our customers come first—our orthodontist clients and their partners are at the heart of everything we do. We anticipate their needs, delivering personalized, effective, and reliable solutions. • Be part of a fast‑moving, mission-driven healthcare company improving patient outcomes., • Participate in regulatory strategy and shape how we operate across EMEA and MEA., • Work in a dynamic, multicultural environment with strong collaboration between Europe and Asia., • Competitive compensation and opportunities for career development. DESCRIPTION We are seeking an experienced Compliance & Regulatory Lead to join our growing team in Madrid. This role is critical to ensure that our operations across EMEA meet the highest regulatory and compliance standards within the medical device industry. You will work closely with our headquarters teams based in China, support regional teams across EMEA and MEA, and act as a trusted regulatory advisor for internal stakeholders and customers. 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. RESPONSIBILITIES 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., • Provide clear regulatory guidance and support to MEAI teams and advise on country‑specific requirements., • Lead regulatory planning and support new country launches, ensuring efficient registration and market entry., • Optimize and continuously improve the complaints handling process to ensure timely and compliant responses. Cross‑Functional Support • 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., • Monitor regulatory changes and ensure timely implementation across relevant teams., • Contribute to internal audits, risk assessments, and continuous compliance improvement initiatives. REQUIRED SKILLS AND QUALIFICATION • 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., • Solid understanding of EU MDR and other international regulatory frameworks., • 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., • Strong communication skills, with the ability to explain complex regulatory matters in a clear and practical way., • Fluent English (spoken & written); additional languages are an advantage., • Strong organizational and project management abilities., • Customer‑oriented mindset and ability to work in the field when needed.

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