- Develop and implement regulatory strategies to ensure compliance with EU MDR;
- Liaise with Notified Bodies and health authorities to address observations, questions, and non-conformities;
- Analyze and manage regulatory changes impacting product portfolios;
- Collaborate with cross-functional teams to advise on regulatory matters throughout the device lifecycle;
RegulatoryAffairsSpecialistwithFocusonEuropeanCompliance - Juiz de Fora - beBeeMedicalDevices
Título do emprego: Regulatory Affairs Specialist
Descrição
Regulatory Affairs Expert for Medical Devices
Job Description:
We are seeking a highly skilled Regulatory Affairs expert to join our team and take on the challenge of ensuring compliance with European regulations (EU MDR) for medical devices. As a key member of our organization, you will be responsible for leading regulatory activities, coordinating technical documentation, and providing expert support in CE Marking processes.
Requirements:
6+ years of experience in Regulatory Affairs for medical devices; Proven experience with European regulations (EU MDR); Strong expertise in Class IIa and IIb medical devices. Experience working with Notified Bodies & health authorities solid knowledge of the regulatory lifecycle of medical devices registration maintenance changes & post-market activities Academic background in Pharmaceutical Chemistry Biomedical Engineering Pharmacy Health Sciences or related field Advanced / fluent English spoken written strong analytical decision-making prioritization skills Leadership autonomy stakeholder management skills international environments