Quality & Regulatory Lead- Medical Devices

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...

Job OverviewWe are seeking a skilled and experienced Quality & Regulatory Lead to spearhead the QA RA function for our medical implants project.The ideal candidate will possess a strong background in quality and/or regulatory roles within the medical device industry, preferably with Class II or III implants. Prior experience in greenfield or startup...

Job SummaryThe Lead Quality Engineer is responsible for supporting new product development and maintenance through the application of quality engineering skills for medical devices.Main ResponsibilitiesCollaborate with cross-functional teams to ensure design control projects are completed successfully.Prioritize experience in Sterilization processes to...

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...

About the RoleThis is an exciting opportunity to lead regulatory affairs in a reputable medical device industry. You will be responsible for planning and preparing submissions for clearances and registrations, ensuring that our products meet the required standards.

This role plays a pivotal part in bringing medical devices to market while ensuring ongoing compliance. Key responsibilities include participating on cross-functional teams, developing global regulatory strategies, authoring regulatory submissions, and interacting with regulatory agencies.The ideal candidate will have expertise in product development...

JOB DETAILS You will plan and lead regulatory affairs, including preparing submissions for clearances and registrations. You will serve as Management Representative for the company's FDA QSR and ISO 13485-compliant quality system, responsible for procedures and policies that meet the requirements of our target markets. You will be a liaison with government...

Job DescriptionQualification:Bachelors or Masters in Biomedical Engineering and at least 2 years of experience in quality management system for medical device (ISO 13485).Experience and skillsA candidate should have hands on experience on implementing qualitymanagement system ISO 13485.Candidates must provide details of QMS projects handled.Knowledge of ISO...

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 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...