9 Mdsap Jobs

Beckman Coulter Life Sciences mission is to empower those seeking answers to life's most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you'll help drive our vision of accelerating answersand our commitment to excellence. Beckman Coulter Life Sciences is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. Do you want to work in Manufa...

Key Responsibilities: Lead preparation and implementation of ISO 13485, MDSAP, and 21 CFR Part 820 compliance. Manage the preparation of the Design Dossier along with other documents and ensure compliance with EU MDR requirements. Conduct gap analysis of client QMS and MDD/MDR documentation. Draft, review, and approve stability study protocols, reports, and validation documentation. Organise and oversee Internal Quality Audits (IQA) and Management Review Meetings (MRMs). Plan and execute predefined visits based on client needs and predetermined agendas. Conduct internal audits of systems and processes to identify non-conformances and drive closure. Update technical documentation (CER, PSUR, ...

About Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of science and technology. For the last 42 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ? 5% every year an achievement unrivalled by any company listed on the London Stock Exchange. Why join us ...

Key Deliverables : Plan and conduct audits in compliance with ISO 13485, EU MDR, and MDSAP standards. Review and evaluate technical files and documentation for medical devices. Collaborate with audit teams to ensure quality, compliance, and client satisfaction. Support certification decisions and regulatory reviews as per DNV and accreditation guidelines. Role Responsibilities : Execute audits independently and manage auditing teams when needed. Maintain audit documentation and timely delivery of reports. Ensure adherence to global regulatory and accreditation standards. Engage with clients and internal stakeholders to support quality assurance.

EY is hiring for Medical Device Assessor/Auditor for one of its clients. Location: Any metropolitan cities Work Mode Work from Home ( need to be flexible with hybrid) General Shift Travel – 100 % (75% Domestic) Notice – Immediate to 60 days Mandatory Skill set: Auditor, Assessor, MDR Assessor certification body in medical devices, regulatory approvals for medical devices. Job Description We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities: Technical Compliances, Acc...

Job Description Position: Executive Manufacturing Production Position Reports to: Associate Manager Manufacturing Downline Reporting: Associate Executives & Operators Location: Jigani, Bangalore, India Job Responsibilities To achieve Daily / Shift targeted production at required quality levels at specified costs in conformance with procedures specified in the quality system by ensuring availability of manpower, machines, and materials. To deliver products on time to the internal customers as per the production plan duly tying up suitable manpower requirement in the Department. To be Responsible for achieve the shift KPI factors such as, Labour Productivity, Optimum utilization of Consumables...

As the Head of Quality and Regulatory Compliance at the India Innovation Center (IIC) in Bangalore, India, you will play a crucial role in leading the Quality and Compliance Groups within the organization. Reporting to the Supervisor Director Quality and Compliance Critical Care, you will be an integral part of the leadership team at Getinge India. Your primary responsibility will be to ensure the effective establishment and maintenance of quality systems in the projects executed at IIC. You will be tasked with providing strategic leadership and management for the Quality Systems at the IIC, developing a competent and accountable Quality organization aligned with business objectives and comp...

Role & responsibilities Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Good Communicator & writing skills. Social Media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Establish rapport and liaison with Regulatory bodies and seek advance information on legal/regulatory introduction/amendments. Connects and actively interacts with Medical Device Industry forums. Generates propos...

Job Description: Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline; 10+ years of professional experience in medical device in Risk management , regulatory Quality systems EU MDR, US FDA and closely working R&D, Regulatory Affairs & design quality organizations Strong proven experience in simplifying/reviewing RMM,BRD, RMF, Trace matrix, DHFs, Design requirements, IFUs, Risk management , V&V activities etc. Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC , ISO. Experience with systems for quality management, product development, and follow-up of procedures Knowledge and application of medica...