6 Samd Jobs

Job Title: QARA + SaMD Specialist (Contract Role) Company: Aegan Technologies Locations: Pune | Chennai | Bangalore | Mumbai | Hyderabad Experience: 3 to 10 Years Join Within: 15 Days Job Description: Aegan Technologies is hiring experienced QARA + SaMD Specialists for a contract-based opportunity. The ideal candidate will be responsible for managing regulatory strategies, ensuring compliance with global standards (FDA, EU MDR, ISO, IEC), and maintaining QMS and DHF documentation for software-based medical devices. Key Responsibilities: Manage regulatory and quality processes for medical devices & SaMD. Ensure compliance with FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 82304 & EU MDR. Prep...

Job Summary: An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device software quality including Software as a Medical Device (SaMD). The ideal candidate will have 310 years of hands-on experience in regulatory strategy, quality systems, and compliance for digital health products and medical device software. This role is critical in ensuring our SaMD offerings meet global regulatory and quality standards across the product lifecycle. Key Responsibilities: Develop and execute regulatory strategies for medical devices including SaMD products across global markets (FDA, EU MDR, etc.). Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO ...

Key Responsibilities Provide regulatory strategy and compliance guidance for SaMD and software-intensive medical devices . Interpret and apply global regulations (FDA, EU MDR, UKCA, Health Canada, etc.) and standards (ISO 13485, IEC 62304, ISO 14971, IEC 82304-1). Prepare and review regulatory submissions (510(k), CE Technical Files, UKCA documentation). Support risk management , cybersecurity compliance , and software lifecycle documentation . Collaborate with engineering teams to align design controls, verification/validation, and usability engineering with regulatory requirements. Stay updated on evolving regulations for AI/ML-based SaMD and digital health solutions. Required Skills & Exp...

The team focusing on Healthy Aging through AI is looking for a talented individual to join their 2019 X-ray AI project under the Global Business Team. The team, led by the CEO, is at the forefront of innovation in healthcare technology, aiming to revolutionize the industry through cutting-edge AI solutions. As a member of this team, your main tasks will include collaborating with Key Opinion Leaders (KOL) to drive the project's success. You will be responsible for setting and achieving key performance indicators (KPI) related to Regulatory Affairs/Quality Assurance (RA/QA), Research and Development (R&D), and more. The ideal candidate for this role should be an Osteo Signal Global Game Chang...

The Medical Affairs Team at X-ray AI is seeking a talented MA Team Leader to join their team. As the MA Team Leader, you will be responsible for developing medical strategies, generating evidence, and gathering medical insights. Your role will also involve communicating with researchers and engaging with Key Opinion Leaders (KOLs). The ideal candidate for this position should have an M.D. (Medical Doctor) degree and possess excellent analytical, communication, and interpersonal skills. Being people smart and having a strong understanding of the healthcare industry will be beneficial for this role. Preferred qualifications include experience with AI, Software as a Medical Device (SaMD), and P...

Greetings, Hope you are doing fine! NOTE: We apologize if any inconvenience is caused or if this job opening is irrelevant / not of interest to you and request you to ignore this mail. We have an job opening with a leading HealthTech company Position: Head of Compliance Location: Bangalore JD: Need a candidate having experience in Compliance, HIPAA, SaMD, and FDA. If interested in the profile, kindly send us your updated CV to debraj.bhattacharya@connexio.asia and ankit.kumar@connexio.asia Also, it would be great if you could help me with the following details Current Fix CTC: Expected CTC: Notice Period: Current Location: Thanks, Mona Shah Recruitment Team Email: mona.shah@connexio.asia