Cybersecurity Expert for Medical Devices
1 month ago
Pramana, 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 our cybersecurity team and ensure our digital pathology solutions meet regulatory requirements and maintain the highest standards of cybersecurity. The ideal candidate will have a deep understanding of medical device cybersecurity, regulatory compliance, and quality management systems, particularly in the context of FDA, CE Mark, and US Federal Government requirements.
Job OverviewThe successful candidate will be responsible for ensuring compliance with FDA cybersecurity guidelines for medical devices, including risk management and mitigation strategies. They will prepare and maintain technical documentation required for CE marking under the EU MDR and collaborate with regulatory affairs to demonstrate substantial equivalence to legally marketed devices, facilitating market clearance.
Key Responsibilities- Regulatory Compliance: Ensure compliance with FDA cybersecurity guidelines for medical devices, including risk management and mitigation strategies.
- FDA 510(k) Submission: Prepare and submit all necessary documentation, including a description of the device's security features and risk management approach.
- Risk Management: Conduct comprehensive risk assessments to identify potential cybersecurity threats and vulnerabilities, and develop and implement risk mitigation strategies to protect our digital pathology systems.
- Quality Management System (QMS): Integrate cybersecurity best practices into our ISO 13485 certified QMS, develop and maintain cybersecurity policies and procedures, and support internal and external audits by providing evidence of cybersecurity measures and their effectiveness.
- Continuous Monitoring and Incident Response: Implement continuous monitoring processes to detect and respond to cybersecurity incidents promptly, and develop and maintain incident response plans to address and mitigate the impact of cybersecurity breaches.
- Collaboration and Training: Work closely with cross-functional teams to ensure cybersecurity is considered at every stage of the product lifecycle, and provide cybersecurity training and awareness programs for employees to foster a culture of security.
- Bachelor's degree in Computer Science, Information Security, or a related field; advanced degree preferred.
- Minimum of 4 years of experience in cybersecurity, preferably in the medical device or healthcare industry.
- In-depth knowledge of FDA cybersecurity guidelines, EU MDR requirements, and US Federal Government cybersecurity standards.
- Experience with ISO 27001 and integrating cybersecurity into QMS.
- Proven track record of successfully navigating the Compliance process.
- Strong understanding of risk management principles and methodologies.
- Excellent problem-solving skills and attention to detail.
- Strong communication and collaboration skills.
$120,000 - $180,000 per year, depending on experience.
-
Medical Device Risk Management Expert
3 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
3 weeks 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...
-
Regulatory Compliance Expert
4 days ago
Bengaluru, Karnataka, India Dozee Full timeAbout the Role:Dozee is seeking a highly skilled Regulatory Compliance Expert - Medical Devices to join our team. As a Regulatory Compliance Expert, you will be responsible for ensuring that our medical devices meet regulatory requirements. This includes planning, establishing, and maintaining a Quality Management System (QMS) in accordance with EN ISO...
-
Medical Device Security Specialist
4 days ago
Bengaluru, Karnataka, India Pramana Full timePramana's Vision :Pramana aims to bring fully autonomous systems to pathology labs, enabling AI-enabled workflows for serving patients. As a key player in this ecosystem, we require a highly skilled Cybersecurity Professional to ensure our digital solutions meet regulatory requirements.Job Description :Work closely with cross-functional teams to ensure...
-
Cybersecurity Professional
4 days ago
Bengaluru, Karnataka, India Pramana Full timeAbout Pramana :Pramana, a leading developer of autonomous systems for pathology labs, seeks an experienced Cybersecurity Professional to ensure the highest standards of cybersecurity in its digital solutions. The ideal candidate will have a deep understanding of medical device cybersecurity, regulatory compliance, and quality management systems.Key...
-
Global Sales Director for Medical Devices
2 weeks 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
2 weeks 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
1 month 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...
-
Medical Device Sales Professional
4 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...
-
Cybersecurity Expert Senior
3 weeks ago
Bengaluru, Karnataka, India Jobs for Humanity Full timeJob OverviewFIS is committed to empowering individuals with the opportunity to work on challenging issues in financial services and technology. This role offers a chance to be part of an innovative team dedicated to delivering cutting-edge solutions.About the PositionThis senior cybersecurity expert will play a crucial role in developing and implementing...
-
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...
-
Cybersecurity Expert
3 weeks ago
Bengaluru, Karnataka, India Crossbow Labs Full timeWe are seeking a highly skilled Cybersecurity Expert to join our team at Crossbow Labs. As a Security Consultant, you will be responsible for conducting risk management and compliance audits for clients.About the RoleAs a Senior Associate in our Security Consulting team, you will play a crucial role in ensuring the security and integrity of our clients'...
-
Cybersecurity Identity Architect
3 days ago
Bengaluru, Karnataka, India AUJAS CYBERSECURITY LIMITED Full timeCybersecurity Identity Expert Sought!AUJAS CYBERSECURITY LIMITED is seeking a highly skilled Ping Directory Specialist to join our team. In this role, you will be responsible for designing and implementing identity management solutions using the Ping Directory Suite. The ideal candidate will have strong understanding of LDAP and directory services,...
-
Bengaluru, Karnataka, India Advanced Sterilization Products Full timeCompany OverviewAdvanced Sterilization Products is a leading provider of innovative solutions for the medical industry.About the JobWe are seeking an experienced Cybersecurity Expert for Enterprise-Class Security Systems. As a key member of our R&D team, you will be responsible for designing and implementing high-performance security systems that meet the...
-
Bengaluru, Karnataka, India Biocon Biologics Full timeJob Description:Biocon Biologics is a leading company in the biosimilars revolution, aiming to impact a billion lives by fostering a culture of affordable innovation, patient centricity, and disruptive thinking.We are seeking an experienced Medical Devices Validation and Verification Expert to join our team. As a key member of our design quality function,...
-
Cybersecurity Solutions Engineer
3 days ago
Bengaluru, Karnataka, India AUJAS CYBERSECURITY LIMITED Full timeJob OverviewWe are seeking a Cybersecurity Solutions Engineer to join our team at AUJAS CYBERSECURITY LIMITED. This role requires a strong technical background in identity security and a proven track record of implementing successful identity management systems.Key Responsibilities:Design and implement secure identity management systems using Ping Directory...
-
Cybersecurity Engineer
1 month ago
Bengaluru, Karnataka, India Cisco Full timeCisco, a leading technology company, is seeking an experienced Cybersecurity Engineer - Networking Expert to join its team. This role offers a competitive salary of $120,000 per annum.About the Role:This position involves working on delivering high-quality fixes for regressions and customer issues with our Security and SD-WAN MX device firmware.As a...
-
Clinical Expert
1 month ago
Bengaluru, Karnataka, India Avana Medical Devices Pvt ltd Full timeJob Title: Clinical Expert - Orthopedic Application SpecialistWe are seeking a highly skilled Clinical Expert to join our team at Avana Medical Devices Pvt Ltd. as an Orthopedic Application Specialist in Bangalore.About the Role:The ideal candidate will have a strong clinical background combined with technical proficiency and experience in the orthopedic...
-
Bengaluru, Karnataka, India Mistral Solutions Private Limited Full timeAbout the RoleWe are seeking a skilled Firmware Development Expert to join our team at Mistral Solutions Private Limited. As a Software Engineer for Medical Devices, you will be responsible for designing and developing integrated software systems and firmware for medical devices.Key Responsibilities:Develop production-worthy engines from proof-of-concept...
-
Regulatory Compliance Expert
4 days ago
Bengaluru, Karnataka, India Pramana Full timeAbout This Role :We are seeking a highly skilled Cybersecurity Professional to join our team and contribute to the development of our autonomous systems for pathology labs. The ideal candidate will have a deep understanding of medical device cybersecurity, regulatory compliance, and quality management systems.Key Responsibilities :Ensure compliance with FDA...
