Job Description
Job details
No matching job preferences
Salary
₹4,000 - ₹12,000 a month
Job type
Full-time
Internship
Shift and schedule
Morning shift
Day shift
Benefits & Perks
Paid sick time
Benefits
Pulled from the full job description
Flexible schedule
Paid sick time
Full Job Description
Lab/Affiliation: UTSAAH Lab, CPDM, Indian Institute of Science, Bangalore
Project: Ikshana - An integrated system for adaptive stimulation treatment of urinary incontinence
(ikshanahealthcare.co.in)
_____________________________________________________________________________________________________
OPEN POSITION: Internship – Regulatory Affairs
Desirable Qualifications: Final year students of Master’s degree in a relevant field of science or engineering or allied health (having at least one semester coursework in medical device regulatory affairs)
Job Brief:
UTSAAH Lab invites applications from students interested to learn about medical device regulations particularly requirements for software contained in a medical device. The selected candidate will get to learn and apply design control process for medical device software including application of risk management for software. The internship will provide the intern the opportunity to adopt some of the learnings gathered from this experience as their academic dissertation work.
Essential Skills Required:
Familiarity with CDSCO, FDA, ISO 13485 and ISO 14+71 requirements for medical devices.
Ability to interpret requirements for medical device software from relevant IEC standards.
Working knowledge of regulations for software as a medical device and mobile medical applications.
Prior experience with SaMD or Mobile Health Apps is an added advantage.
Demonstrates interest in understanding medical device risk management process.
Ability to research and identify relevant regulatory requirements from relevant health authorities and guidelines as demanded by project tasks.
Must be a good written and oral communicator.
Proficient in MS-Office Tools.
Professional conduct including ability to motivate team members to follow decorum.
Excellent attention to detail and thorough documentation.
Comfortable working in a dynamic and fast-paced environment.
Task: The selected staff is expected to:
A. Design Control for medical devices:
Preparing design inputs, requirements traceability matrix for a mobile health application.
Research regulations for mobile health applications and identify compliance requirements.
Compile design packages from independent divisions into design output documents.
Understand and implement documentation necessary to comply with requirements of IEC 62304.
B. Risk Management for medical devices:
Implementation of risk management according to ISO 14+71 for medical device software; compile risk management reports.
Research cybersecurity standards and document threats and vulnerabilities and mitigation strategies.
Assist the engineering team to undertake FMEA in their respective designs.
Research medical device databases to identify hazards for similar medical devices and participate in risk assessment.
C. Regulatory Information Management:
Conduct research about new regulations and guidance documents and provide periodic updates in team meetings.
Maintain and organize regulatory data in controlled spreadsheets.
D. QMS support:
Assist in the preparation and implementation of SOPs and WIs necessary to establish compliance with requirements of ISO 13485.
Organize and participate in trainings on QMS and Risk management for team members.
Commitment Required: Minimum 6 months, starting as soon as possible.
Why work with us:
1. Real world experience: Self-driven, independent study and critical thinking experience, built with expert internal and external help to build a framework that has a real-world application.
2. Startup Life: Dynamic, new, and impactful. You won’tbe another cog in the wheel here. We give you full trust and autonomyfor you to be heard, to work on a big project and to make a real difference.
3. Mentorship: Shadowing, mentoring, and training opportunities with experienced, knowledgeable professionals.A work opportunity at Indian Institute of Science is highly coveted.
4. Professional growth: Upon completion of contract period, and if agreed upon by both parties, there will be opportunity for a full-time job role with the companybased on successful performance review.
Job Types: Full-time, Internship
Contract length: 6 months
Salary: ₹4,000.00 - ₹12,000.00 per month
Benefits:
Flexible schedule
Paid sick time
Schedule:
Day shift
Morning shift
Supplemental pay types:
Performance bonus
Shift allowance
COVID-1+ considerations:
Yes, all COVID precautions are taken.
Ability to commute/relocate:
IISc Campus, Bangalore, Bengaluru - 560012, Karnataka: Reliably commute or planning to relocate before starting work (Required)
Hiring Insights
Application response rate: 55%
Hiring 1 candidate for this role
Job activity
Posted Today
No matching job preferences
Salary
₹4,000 - ₹12,000 a month
Job type
Full-time
Internship
Shift and schedule
Morning shift
Day shift
Benefits & Perks
Paid sick time
Benefits
Pulled from the full job description
Flexible schedule
Paid sick time
Full Job Description
Lab/Affiliation: UTSAAH Lab, CPDM, Indian Institute of Science, Bangalore
Project: Ikshana - An integrated system for adaptive stimulation treatment of urinary incontinence
(ikshanahealthcare.co.in)
_____________________________________________________________________________________________________
OPEN POSITION: Internship – Regulatory Affairs
Desirable Qualifications: Final year students of Master’s degree in a relevant field of science or engineering or allied health (having at least one semester coursework in medical device regulatory affairs)
Job Brief:
UTSAAH Lab invites applications from students interested to learn about medical device regulations particularly requirements for software contained in a medical device. The selected candidate will get to learn and apply design control process for medical device software including application of risk management for software. The internship will provide the intern the opportunity to adopt some of the learnings gathered from this experience as their academic dissertation work.
Essential Skills Required:
Familiarity with CDSCO, FDA, ISO 13485 and ISO 14+71 requirements for medical devices.
Ability to interpret requirements for medical device software from relevant IEC standards.
Working knowledge of regulations for software as a medical device and mobile medical applications.
Prior experience with SaMD or Mobile Health Apps is an added advantage.
Demonstrates interest in understanding medical device risk management process.
Ability to research and identify relevant regulatory requirements from relevant health authorities and guidelines as demanded by project tasks.
Must be a good written and oral communicator.
Proficient in MS-Office Tools.
Professional conduct including ability to motivate team members to follow decorum.
Excellent attention to detail and thorough documentation.
Comfortable working in a dynamic and fast-paced environment.
Task: The selected staff is expected to:
A. Design Control for medical devices:
Preparing design inputs, requirements traceability matrix for a mobile health application.
Research regulations for mobile health applications and identify compliance requirements.
Compile design packages from independent divisions into design output documents.
Understand and implement documentation necessary to comply with requirements of IEC 62304.
B. Risk Management for medical devices:
Implementation of risk management according to ISO 14+71 for medical device software; compile risk management reports.
Research cybersecurity standards and document threats and vulnerabilities and mitigation strategies.
Assist the engineering team to undertake FMEA in their respective designs.
Research medical device databases to identify hazards for similar medical devices and participate in risk assessment.
C. Regulatory Information Management:
Conduct research about new regulations and guidance documents and provide periodic updates in team meetings.
Maintain and organize regulatory data in controlled spreadsheets.
D. QMS support:
Assist in the preparation and implementation of SOPs and WIs necessary to establish compliance with requirements of ISO 13485.
Organize and participate in trainings on QMS and Risk management for team members.
Commitment Required: Minimum 6 months, starting as soon as possible.
Why work with us:
1. Real world experience: Self-driven, independent study and critical thinking experience, built with expert internal and external help to build a framework that has a real-world application.
2. Startup Life: Dynamic, new, and impactful. You won’tbe another cog in the wheel here. We give you full trust and autonomyfor you to be heard, to work on a big project and to make a real difference.
3. Mentorship: Shadowing, mentoring, and training opportunities with experienced, knowledgeable professionals.A work opportunity at Indian Institute of Science is highly coveted.
4. Professional growth: Upon completion of contract period, and if agreed upon by both parties, there will be opportunity for a full-time job role with the companybased on successful performance review.
Job Types: Full-time, Internship
Contract length: 6 months
Salary: ₹4,000.00 - ₹12,000.00 per month
Benefits:
Flexible schedule
Paid sick time
Schedule:
Day shift
Morning shift
Supplemental pay types:
Performance bonus
Shift allowance
COVID-1+ considerations:
Yes, all COVID precautions are taken.
Ability to commute/relocate:
IISc Campus, Bangalore, Bengaluru - 560012, Karnataka: Reliably commute or planning to relocate before starting work (Required)
Hiring Insights
Application response rate: 55%
Hiring 1 candidate for this role
Job activity
Posted Today
💡 Quick Summary
Seeking a career-building opportunity? The Regulatory Affairs Intern position is now open for candidates interested in the MIS Executive sector. This role in bengaluru offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in MIS Executive is a plus.
