Regulatory Affairs Associate
Regulatory Affairs Associate Interview Questions and Answers
Q1. Procedures for variation
Procedures for variation involve submitting a variation application to regulatory authorities for approval.
Variation application should include detailed information on the proposed changes
Regulatory authorities may require supporting data or documentation to support the variation
Variation procedures may vary depending on the specific regulations and guidelines of the country or region
Changes to labeling, manufacturing processes, or formulation may require variation applicatio...read more
Q2. Mdd and MDR transition difference
The main difference between MDD and MDR transition is the increased requirements for medical device manufacturers under MDR.
MDD (Medical Device Directive) is the previous regulatory framework for medical devices in the EU, while MDR (Medical Device Regulation) is the updated and more stringent regulation.
MDR introduces new classification rules, stricter post-market surveillance requirements, and enhanced transparency through the EUDAMED database.
Manufacturers need to comply w...read more
Q3. Types of variation
Variations in regulatory submissions include major, minor, and administrative changes.
Major variations involve significant changes to the product, such as formulation or indication.
Minor variations are less significant changes, like packaging updates.
Administrative variations are minor administrative changes, like contact details.
Examples: Major - adding a new indication, Minor - updating packaging design, Administrative - changing contact information
Q4. Mdr regulation 2017/245
MDR regulation 2017/245 is a regulation that governs medical devices in the European Union.
MDR regulation 2017/245 replaces the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).
It introduces new requirements for medical device manufacturers, importers, and distributors.
The regulation aims to improve patient safety and ensure the quality and performance of medical devices.
MDR regulation 2017/245 also includes stricter rules for cl...read more
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