Leading Medical Device Regulatory Expert

Opportunity to lead QA RA for medical implants greenfield projectSet up and maintain the Quality Management System in ISO 13485About Our ClientGlobal medical devices client in the space of orthopedic implantsJob DescriptionRegulatory Affairs:Lead interactions with Indian health authorities (CDSCO) for the registration and continued compliance of our implants...

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...

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 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...

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: Medical Device Risk ManagerThis role focuses on leading risk management initiatives for medical devices and health software. Our ideal candidate has extensive experience in the industry, with a strong background in project management and risk analysis.Key Responsibilities:Develop and implement risk management strategies to ensure product safety...

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...

Medical Devices Hardware Development EngineerWe are seeking a skilled and experienced engineer to design, develop, and implement medical devices hardware.The ideal candidate will have a strong background in electrical engineering, with expertise in analog/digital circuit design, embedded systems, and PCB development. Additionally, they will be familiar with...

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...