Outstanding that you're thinking about a career with BSI

Position:
Medical devices auditor

Location:
India(home based)

What Duties You'll Perform
- As a Regulatory Services business stream Client Manager(Auditor) you'll be responsible for frequently travelling and having overnight stays across the South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe.
- You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).

About BSI And The Regulatory Services Team
- BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.




- Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.

Key Responsibilities & Accountabilities
- Undertake management system assessments in accordance with BSI requirements.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clien

📌 Medical devices auditor(talent pipeline) (India)
🏢 BSI
📍 India