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Infosys Regulatory Affairs Consultant Interview Questions, Process, and Tips

Updated 17 Mar 2022

Infosys Regulatory Affairs Consultant Interview Experiences

1 interview found

I applied via Naukri.com and was interviewed in Sep 2021. There was 1 interview round.

Round 1 - Technical 

(5 Questions)

  • Q1. Describe about iso 14971 and how to prepare a typical risk management report with an example
  • Q2. What are the clauses available in ISO 13485
  • Q3. Describe about SDLC and explain about IEC 62304
  • Q4. Explain about EU MDR and FDA regulatory requirements
  • Q5. Difference between Quality and Regulatory Affairs

Interview Preparation Tips

Topics to prepare for Infosys Regulatory Affairs Consultant interview:
  • IEC 62304
  • Iso 14971
  • SDLC Life Cycle
Interview preparation tips for other job seekers - Be prepared on your JD and your CV points,
Be clear in your skills and shout with typical examples for each answers, that makes your Interviewer to understand the points clear.
Do specific on your present roles and express your eagerness in learning.

Skills evaluated in this interview

Interview questions from similar companies

Interview experience
3
Average
Difficulty level
-
Process Duration
-
Result
-
Round 1 - One-on-one 

(2 Questions)

  • Q1. Explain your work that you mentioned in CV
  • Ans. 

    I have experience in preparing regulatory submissions, ensuring compliance with regulations, and communicating with regulatory agencies.

    • Prepared regulatory submissions for new products and changes to existing products

    • Ensured compliance with relevant regulations and guidelines

    • Communicated with regulatory agencies to address any issues or questions

    • Reviewed and updated regulatory documentation as needed

  • Answered by AI
  • Q2. Any tricky question relevant to their field

Interview Preparation Tips

Interview preparation tips for other job seekers - Job search on Naukri.com on daily basis , then your profile get highlighted
Interview experience
1
Bad
Difficulty level
Moderate
Process Duration
More than 8 weeks
Result
Selected Selected

I applied via Referral and was interviewed before Dec 2023. There were 2 interview rounds.

Round 1 - Technical 

(2 Questions)

  • Q1. Clinical trials type
  • Q2. What is regulatory affairs
  • Ans. 

    Regulatory affairs involve ensuring compliance with laws and regulations related to products and services.

    • Regulatory affairs involve interpreting and implementing regulations set by government agencies.

    • They ensure products meet safety and quality standards before being marketed.

    • Regulatory affairs professionals work to obtain and maintain product approvals and registrations.

    • They also monitor and report any changes in re...

  • Answered by AI
Round 2 - HR 

(1 Question)

  • Q1. Job location in which state
  • Ans. 

    The job location is in California.

    • Job location is in California

    • Specific city within California may vary

    • California is known for its strict regulatory environment

    • Many pharmaceutical and biotech companies are based in California

  • Answered by AI

Interview Preparation Tips

Interview preparation tips for other job seekers - Please speed up the process, for me it's takes 3 months
Interview experience
2
Poor
Difficulty level
Moderate
Process Duration
6-8 weeks
Result
Selected Selected

I applied via Referral and was interviewed before Sep 2022. There were 3 interview rounds.

Round 1 - Resume Shortlist 
Pro Tip by AmbitionBox:
Keep your resume crisp and to the point. A recruiter looks at your resume for an average of 6 seconds, make sure to leave the best impression.
View all tips
Round 2 - Aptitude Test 

General apti tests were there, you can try NQT test samples in TCS carer NQT website

Round 3 - Behavioral 

(5 Questions)

  • Q1. Project related and technical questions
  • Q2. Regulatory Affairs, CTA
  • Q3. Clinical trials
  • Q4. Devolopment of new drugs
  • Q5. NDA, IND, ANDA, Health authority names

Interview Preparation Tips

Interview preparation tips for other job seekers - Good communication skill required

I applied via Naukri.com and was interviewed before Aug 2021. There was 1 interview round.

Round 1 - Technical 

(2 Questions)

  • Q1. Explain the project which you handled in previous organisation
  • Q2. What ISO13485 and explain the clauses

Interview Preparation Tips

Interview preparation tips for other job seekers - Be clear on what you have and accept if you don't the answer for the question

I applied via Referral and was interviewed in Sep 2020. There were 3 interview rounds.

Interview Questionnaire 

1 Question

  • Q1. About ISO 13485,ISO 14971,New Product development,IEC 60601,

Interview Preparation Tips

Interview preparation tips for other job seekers - Do it with confidence...

I applied via Referral and was interviewed before Oct 2020. There was 1 interview round.

Interview Questionnaire 

1 Question

  • Q1. Medical device regulation

Interview Preparation Tips

Interview preparation tips for other job seekers - MDR 2017 is correct answer

Infosys Interview FAQs

How many rounds are there in Infosys Regulatory Affairs Consultant interview?
Infosys interview process usually has 1 rounds. The most common rounds in the Infosys interview process are Technical.
What are the top questions asked in Infosys Regulatory Affairs Consultant interview?

Some of the top questions asked at the Infosys Regulatory Affairs Consultant interview -

  1. Describe about iso 14971 and how to prepare a typical risk management report wi...read more
  2. What are the clauses available in ISO 13...read more
  3. Explain about EU MDR and FDA regulatory requireme...read more

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Infosys Regulatory Affairs Consultant Reviews and Ratings

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5.0/5

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