Medical Device Auditor Lead
6 days ago
Job Overview
This position is part of the UL Medical Regulatory Team and involves working with highly regulated Medical Devices.
As an Auditor/Lead Auditor, you will independently assist and support processing of manufacturer submissions to various regulatory programs, including ISO13485, MDSAP, UKCA Medical Device Regulation 2002, CE Medical Device Regulation 2017/745, and InMetro.
Responsibilities:
- Support contract review/agenda setting for quality management system audits
- Regularly conduct quality system and technical audits, including CE and UKCA unannounced audits
- Timely preparation of audit reports and customer Corrective and Preventive Action analysis and responses
- Subject to training and qualification milestones, perform key Quality Management System audit activities to ensure safe products reach the market
- Participate in development of UL requirements and assessment methods
- Provide guidance and support to customers as required, participating in client training and forums
- National/international travel (50% to 75%) is necessary
Requirements
The ideal candidate should possess a Bachelor's degree, preferably in a field like Pharmacy, Engineering, Technology, or similar. At least four years' professional experience in healthcare products or related fields are required, with two years in quality management. Strong knowledge of manufacturing methods for Medical Devices and legislation relevant harmonized standards are essential.
Compensation
We offer a competitive salary between $90,000 to $110,000 annually, depending on experience and qualifications. The exact compensation can be discussed during the hiring process.
-
Global Sales Director for Medical Devices
4 days ago
Bengaluru, Karnataka, India Concept Medical Full timeAbout Concept Medical:We are a leading global medical device company specializing in innovative stents and balloon catheters for interventional cardiology and radiology.Position Summary:This senior role demands a strategic leader with deep understanding of the healthcare landscape, exceptional sales acumen, and ability to build and nurture relationships with...
-
Global Sales Leader for Medical Devices
4 days ago
Bengaluru, Karnataka, India Concept Medical Full timeAbout Concept Medical:Concept Medical is a pioneering medical devices company specializing in the development and manufacturing of innovative stents and balloon catheters for interventional cardiology and radiology. Our mission is to revolutionize patient care with cutting-edge products that enhance clinical outcomes.We are seeking an experienced Area Sales...
-
Regional Sales Director
4 weeks ago
Bengaluru, Karnataka, India Concept Medical Full timeAbout Concept Medical:A global leader in medical devices, specializing in innovative stents and balloon catheters for interventional cardiology and radiology.As we expand in India, we seek a seasoned Regional Sales Director to lead sales operations, drive revenue growth, and expand market penetration.Key Responsibilities:Craft and execute comprehensive sales...
-
Bengaluru, Karnataka, India Motherson Health & Medical Full timeCompany OverviewMotherson Health & Medical is a leading medical device company that designs and develops innovative solutions to improve patient outcomes. We are seeking an experienced Senior Electronic Hardware Engineer to join our team.About the RoleWe are looking for a highly skilled Senior Electronic Hardware Engineer to lead the design and development...
-
Bengaluru, Karnataka, India Biorad Medisys Pvt Ltd Full timeJob Title: Senior Medical Device System Design and Development LeadAbout the Role:As a Senior Medical Device System Design and Development Lead at Biorad Medisys Pvt Ltd, you will be responsible for leading the development of cutting-edge medical devices by overseeing both software and hardware engineering teams.Key Responsibilities:• Lead and mentor a...
-
Medical Device Testing Specialist
3 days ago
Bengaluru, Karnataka, India NeST Digital Full timeAre you a seasoned professional with 6-8 years of experience in medical device testing? Do you possess in-depth knowledge of medical standards and regulations?About NeST DigitalWe are a leading technology firm dedicated to delivering innovative solutions in the medical device sector. Our team is passionate about creating cutting-edge products that meet the...
-
Medical Device Test Specialist
3 weeks ago
Bengaluru, Karnataka, India Baxter Full timeBaxter: Revolutionizing Medical InnovationWe are seeking a highly skilled Medical Device Test Specialist to join our team at Baxter, a leading global medical technology company.As a key member of our organization, you will play a critical role in ensuring the quality and safety of our medical devices, from design to delivery.The ideal candidate will possess...
-
Senior Medical Device System Architect
2 weeks ago
Bengaluru, Karnataka, India Biorad Medisys Pvt Ltd Full timeJob Description:Biorad Medisys Pvt Ltd is seeking a highly experienced Senior Medical Device System Architect to lead the development of cutting-edge medical devices by overseeing software and hardware engineering teams.The ideal candidate will possess extensive experience in system design and architecture, managing cross-functional teams, and collaborating...
-
Medical Device Risk Management Expert
2 weeks ago
Bengaluru, Karnataka, India Philips Full timeRole OverviewWe are seeking a highly skilled Medical Device Risk Management Expert to join our Design Quality Engineering Team.Job DescriptionThe successful candidate will be responsible for managing product safety, property, and environmental risk, leading Risk Management efforts, processes, and process improvements for assigned product/business portfolio....
-
Medical Device Compliance Expert
1 week ago
Bengaluru, Karnataka, India Dozee Full timeJob SummaryWe are seeking a Medical Device Compliance Expert to join our team at Dozee, an AI-based contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) company.About the Role:The successful candidate will be responsible for ensuring compliance with regulatory requirements, implementing quality management systems, and maintaining...
-
Medical Device Sales Professional
3 weeks ago
Bengaluru, Karnataka, India Sofomation Full timeAbout the RoleWe are seeking a seasoned Medical Device Sales Executive to join our team at Sofomation.As a key member of our sales team, you will be responsible for driving revenue growth and expanding our presence in the medical device market.Key ResponsibilitiesPromote and sell medical devices to hospitals, clinics, and other healthcare institutions in...
-
Bengaluru, Karnataka, India Motherson Health & Medical Full timeDesign and Development of Electronic Hardware SubsystemsMotherson Health & Medical is seeking an experienced Electronics Hardware Design Engineer to join our team. The ideal candidate will have a strong background in electronic hardware design, development, and testing.Key Responsibilities:Design and develop electronic hardware subsystems, including...
-
Business Development Manager for Medical Devices
2 weeks ago
Bengaluru, Karnataka, India 2coms Full timeWe are seeking a results-driven Business Development Manager to lead our sales team and drive business growth in Bangalore.About 2coms2coms is a leading medical devices company looking for a talented individual to join our team. As a Business Development Manager, you will play a crucial role in driving sales growth and developing strategic relationships with...
-
Design Engineer for Medical Devices
2 weeks ago
Bengaluru, Karnataka, India Halma plc Full timeAbout Halma plcA global leader in life-saving technologies, driven by a clear purpose to innovate and improve lives.Our company has a long history of growth and success, with operations in 23 countries and a team of over 250 professionals across various functions.We are committed to creating a safe and respectful workplace where everyone can thrive and bring...
-
Electronics Hardware Design Specialist
7 days ago
Bengaluru, Karnataka, India Motherson Health & Medical Full timeJob DescriptionMotherson Health & Medical is seeking an experienced Electronics Hardware Design Specialist to join our team.About the RoleThe successful candidate will be responsible for designing and developing electronic hardware subsystems, including high and low-speed multilayer PCB design, in accordance with IEC standards.Key Responsibilities:Design and...
-
Bengaluru, Karnataka, India Advanced Sterilization Products Full timeCompany OverviewAdvanced Sterilization Products (ASP) is a leading manufacturer of medical devices and equipment. We are committed to providing innovative solutions that improve patient outcomes.Salary$120,000 - $180,000 per year, depending on experience.Job DescriptionWe are seeking an experienced Embedded Software Engineer to lead the development of our...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Bengaluru, Karnataka, India L&T Technology Services Full timeJob Summary:">We are seeking a highly skilled Medical Device Testing professional to join our team at L&T Technology Services. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in medical device testing.About Us:">L&T Technology Services is a leading global technology consulting and digital...
-
Medical Device Regulatory Compliance Specialist
2 weeks ago
Bengaluru, Karnataka, India Dozee Full time**Job Overview**">We are seeking a highly skilled Medical Device Regulatory Compliance Specialist to join our team at Dozee.As a Medical Device Regulatory Compliance Specialist, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements. You will be responsible for planning, implementing, and maintaining a...
-
Financial Compliance Auditor
2 weeks ago
Bengaluru, Karnataka, India East Point College of Medical Science & Research Centre Full timeJob SummaryWe are seeking a highly skilled Financial Compliance Auditor to join our team at East Point College of Medical Science & Research Centre.About UsEast Point College of Medical Science & Research Centre is a leading educational institution dedicated to providing high-quality medical education and research opportunities.Key ResponsibilitiesThe...
-
Cybersecurity Expert for Medical Devices
4 weeks ago
Bengaluru, Karnataka, India Pramana Full timeAbout PramanaPramana, a pioneering company in Cambridge, MA, USA, is expanding its team with a highly skilled Cybersecurity Professional. With R&D and manufacturing sites in Bangalore (India), Rochester (MN, USA) and Toronto (Canada), Pramana is revolutionizing the pathology lab landscape with AI-enabled workflows.We are seeking an experienced expert to join...