Medical Device Compliance Specialist

Job Description:Define the strategic direction and compliance-focused features for Electronic Device History Record (EDHR) platforms to ensure regulatory standards.Translate regulatory frameworks (21 CFR Part 820, EU MDR, ISO into digital product specifications that meet business objectives.Lead the integration of EDHR with MES, PLM, and QMS systems in...

Medical Device Regulatory Compliance SpecialistThe role of the Medical Device Regulatory Compliance Specialist is to ensure that medical devices are compliant with regulatory requirements. This includes ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.Key Responsibilities:Coordinate with regulatory authorities for obtaining required...

Device Engineering ExpertiseWe are seeking an experienced Device Engineer with a strong background in medical devices and quality management.Key ResponsibilitiesConduct thorough assessments and audits of medical devices to ensure compliance with regulatory requirements such as ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.Develop and...

Job DescriptionAs a regulatory compliance executive, you will play a crucial role in ensuring that our products meet the highest standards of safety and efficacy. You will be responsible for reviewing product labelling and advertising materials to ensure they comply with regulatory requirements.You will also contribute to the complaint handling process and...

Our company is seeking a highly skilled and experienced Quality Assurance Specialist to join their ranks. This individual will be responsible for managing quality assurance procedures and records, planning and guiding lab tests for innovative medical devices, and preparing and submitting device dossiers to regulatory bodies.Main Responsibilities:Manage...

Our company operates in a global environment with a diverse group of life-saving technology companies. Our purpose is to innovate and drive technologies that push the boundaries of science.Key Responsibilities:The Regulatory Affairs Executive will be responsible for collaborating with international teams, providing guidance on compliance, and developing...

Job Summary:We are seeking a skilled and experienced electrical engineer to join our R&D team. The ideal candidate will have a strong background in hardware development, with expertise in analog/digital circuit design, embedded systems, and PCB development.This role involves collaborating cross-functionally with design, compliance, testing, and manufacturing...

Biomedical Equipment Specialist">">The ideal candidate will have a strong background in biomedical engineering, with experience in the maintenance and repair of complex medical equipment. We are looking for an individual who is detail-oriented and has excellent problem-solving skills.We prioritize quality and safety in our hospital's equipment management...

Job TitleMedical device packaging specialists play a crucial role in ensuring the safe and effective delivery of medical devices to patients. In this key position, you will be responsible for supporting technical activities such as running engineering tests, performing biocompatibility on packaging, and assessing sterilization impacts.Key...

Job Title: Biomedical EngineerWe are seeking a highly motivated and skilled Biomedical Engineer to join our team. The successful candidate will be responsible for supporting the research and development of medical devices, equipment, and technology.Key Responsibilities:Support the design and testing of medical devices to ensure they meet safety, quality, and...