Upload Button Icon Add office photos

Filter interviews by

AliveCor Senior Regulatory Affairs Specialist Interview Questions and Answers

Updated 14 Dec 2024

AliveCor Senior Regulatory Affairs Specialist Interview Experiences

1 interview found

Interview experience
1
Bad
Difficulty level
Hard
Process Duration
More than 8 weeks
Result
Selected Selected

I applied via Approached by Company and was interviewed before Dec 2023. There were 5 interview rounds.

Round 1 - Technical 

(2 Questions)

  • Q1. What is the process for the European Union Medical Device Regulation (EU MDR) and its implications for Software as a Medical Device (SaMD)?
  • Q2. What are the labeling requirements?
  • Ans. 

    Labeling requirements for products in the regulatory field include providing accurate and clear information to consumers.

    • Labels must include product name, ingredients, warnings, directions for use, and contact information for the manufacturer.

    • Labels should be in the language of the country where the product is being sold.

    • Certain products may require specific labeling such as nutritional information for food products or...

  • Answered by AI
Round 2 - Technical 

(1 Question)

  • Q1. What are the US FDA requirements for 510(k) and Premarket Approval (PMA)?
Round 3 - Technical 

(1 Question)

  • Q1. Top management requirement
  • Ans. 

    Top management requires clear communication, strategic thinking, and decision-making skills.

    • Clear communication skills are essential for effectively conveying regulatory information to senior management.

    • Strategic thinking is necessary to anticipate potential regulatory challenges and develop proactive solutions.

    • Strong decision-making skills are crucial for navigating complex regulatory environments and making informed ...

  • Answered by AI
Round 4 - Technical 

(1 Question)

  • Q1. CAPA, Quality, Audit
Round 5 - HR 

(1 Question)

  • Q1. Company Suitable

Interview Preparation Tips

Interview preparation tips for other job seekers - Avoid attempting to engage with this organization.

AliveCor Interview FAQs

How many rounds are there in AliveCor Senior Regulatory Affairs Specialist interview?
AliveCor interview process usually has 5 rounds. The most common rounds in the AliveCor interview process are Technical and HR.
How to prepare for AliveCor Senior Regulatory Affairs Specialist interview?
Go through your CV in detail and study all the technologies mentioned in your CV. Prepare at least two technologies or languages in depth if you are appearing for a technical interview at AliveCor. The most common topics and skills that interviewers at AliveCor expect are Regulatory Affairs, Analytical Chemistry, Compliance, FDA and Licensing.
What are the top questions asked in AliveCor Senior Regulatory Affairs Specialist interview?

Some of the top questions asked at the AliveCor Senior Regulatory Affairs Specialist interview -

  1. What is the process for the European Union Medical Device Regulation (EU MDR) a...read more
  2. What are the US FDA requirements for 510(k) and Premarket Approval (PM...read more
  3. What are the labeling requiremen...read more

Tell us how to improve this page.

AliveCor Senior Regulatory Affairs Specialist Interview Process

based on 1 interview

Interview experience

1
  
Bad
View more

Interview Questions from Similar Companies

Apollo Hospitals Interview Questions
4.1
 • 341 Interviews
Tata 1mg Interview Questions
3.6
 • 146 Interviews
Max Healthcare Interview Questions
4.1
 • 135 Interviews
PharmEasy Interview Questions
3.7
 • 80 Interviews
Practo Interview Questions
3.2
 • 74 Interviews
Wayfair Interview Questions
3.7
 • 56 Interviews
Netmeds.com Interview Questions
3.6
 • 42 Interviews
Medlife Interview Questions
3.7
 • 27 Interviews
Portea Medical Interview Questions
4.3
 • 26 Interviews
Keyence Interview Questions
4.2
 • 24 Interviews
View all

AliveCor Senior Regulatory Affairs Specialist Reviews and Ratings

based on 1 review

1.0/5

Rating in categories

1.0

Skill development

4.0

Work-life balance

5.0

Salary

1.0

Job security

1.0

Company culture

1.0

Promotions

1.0

Work satisfaction

Explore 1 Review and Rating
Business Manager
7 salaries
unlock blur

₹4.9 L/yr - ₹7.5 L/yr

Senior Software Engineer
7 salaries
unlock blur

₹24 L/yr - ₹30 L/yr

Engagement Manager
5 salaries
unlock blur

₹30 L/yr - ₹33 L/yr

Program Manager
4 salaries
unlock blur

₹33 L/yr - ₹37 L/yr

Senior Business Analyst
4 salaries
unlock blur

₹18 L/yr - ₹21.5 L/yr

Explore more salaries
Compare AliveCor with

Portea Medical

4.3
Compare

Practo

3.2
Compare

Lybrate

3.5
Compare

PharmEasy

3.7
Compare
Did you find this page helpful?
Yes No
write
Share an Interview