Regulatory Affairs Executive- Documentation

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Posted:2 weeks ago| Platform: Linkedin logo

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Job Description

𝗛𝗶𝗿𝗶𝗻𝗴: 𝗕𝗶𝗼𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗘𝗻𝗴𝗶𝗻𝗲𝗲𝗿 (𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲) – 𝗥&𝗗 & 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻

𝗖𝗼𝗺𝗽𝗮𝗻𝘆: Wrig Nanosystems Pvt. Ltd.

𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻:Parwanoo, Himachal Pradesh

📌 𝗥𝗼𝗹𝗲 𝗦𝘂𝗺𝗺𝗮𝗿𝘆

Seeking a Biomedical Engineer with a software background to support R&D and Regulatory teams in medical device software documentation.

🛠 𝗞𝗲𝘆 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀

Prepare SDLC documents (IEC 62304)

Support software risk management (ISO 14971)

Create SRS, SDD, V&V docs

Assist in testing & traceability

Manage bug tracking & version control

Support SaMD/SiMD regulatory documentation

Contribute to cybersecurity & usability (IEC 62366-1)

💻 𝗦𝗸𝗶𝗹𝗹𝘀

Python / C / C++ / MATLAB / LabVIEW

Understanding of IEC 62304, ISO 14971

Strong documentation & regulatory knowledge

🎓 𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻

B.Tech/M.Tech in Biomedical Engineering, Electronics, or related fields.

📩 𝗔𝗽𝗽𝗹𝘆

Send your CV to anchal.sharma@wrig.in

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