10+ Regulatory Affairs Specialist Interview Questions and Answers

ISO 10993-1 is used to evaluate the biological safety of medical devices.

• I use ISO 10993-1 to determine the appropriate biological tests to perform on medical devices.

• I ensure that the medical devices I work on comply with the biological safety requirements outlined in ISO 10993-1.

• I review and interpret the results of biological tests performed on medical devices according to ISO 10993-1.

• I collaborate with other departments to ensure that all aspects of the medical device, in...read more

Risk in a Risk Management File is documented through a structured process of identification, analysis, evaluation, and control.

• Identify potential hazards and risks associated with the product or process

• Analyze the likelihood and severity of each identified risk

• Evaluate the risk and determine if it is acceptable or requires further control measures

• Document the risk management process and results in a Risk Management File

• Update the Risk Management File as necessary throughout t...read more

Risk refers to the potential harm that may arise from the use of a medical device or drug. Intended purpose is the intended use of the device or drug.

• Risk is the potential harm that may arise from the use of a medical device or drug

• Intended purpose is the intended use of the device or drug

• Risk assessment is an important part of regulatory affairs

• Intended purpose is determined by the manufacturer and approved by regulatory agencies

• Examples of intended purpose include treatment...read more

EUMDR 2017/745 is a regulation that governs medical devices in the European Union.

• Annex I lists the general safety and performance requirements for medical devices.

• Annex II outlines the technical documentation that must be provided for conformity assessment.

• The regulation replaces the previous Medical Device Directive (MDD) and introduces new requirements for manufacturers.

• It also includes a unique device identification (UDI) system to improve traceability and transparency.

• Th...read more

ISO 13485 is a quality management system standard for medical devices.

• ISO 13485 specifies requirements for a quality management system specific to medical devices

• It includes clauses on management responsibility, resource management, product realization, and measurement, analysis, and improvement

• Clause 4 covers general requirements, clause 5 covers management responsibility, clause 6 covers resource management, clause 7 covers product realization, and clause 8 covers measureme...read more

US FDA RTR criteria include major and minor deficiencies for regulatory submissions.

• Major deficiencies are issues that could significantly impact the safety, effectiveness, or quality of the product.

• Minor deficiencies are less critical issues that do not significantly impact the safety, effectiveness, or quality of the product.

• Examples of major deficiencies include missing critical data in a clinical study or failure to meet regulatory requirements for labeling.

• Examples of mi...read more

Regulatory Affairs Specialists must be well-versed in both domestic and international regulations to ensure compliance.

• Regulatory Affairs Specialists must stay up-to-date on changes in domestic regulations set by agencies like the FDA in the US.

• They also need to be knowledgeable about international regulations such as the European Medicines Agency (EMA) guidelines.

• Understanding the differences between domestic and international regulations is crucial for successful product re...read more

Qualitative tests are tests that determine the presence or absence of a substance or condition.

• Qualitative tests are used to identify the presence or absence of a specific substance or condition.

• They do not measure the quantity of the substance or condition.

• Examples of qualitative tests include pregnancy tests, drug tests, and HIV tests.

My expected CTC is in line with industry standards for a Regulatory Affairs Specialist role.

• I have researched the average salary range for Regulatory Affairs Specialists in this region

• I am looking for a competitive salary package that reflects my skills and experience

• I am open to negotiation based on the overall compensation package offered by the company

ANDA requirements for liquid products include submission of bioequivalence data, formulation details, and labeling information.

• Bioequivalence data must demonstrate that the generic product is equivalent to the reference listed drug.

• Formulation details should include information on the active ingredients, excipients, and manufacturing process.

• Labeling information should be consistent with the reference listed drug and include all required warnings and instructions.

• ANDA submiss...read more

Quality control is a process that ensures products or services meet specified requirements and standards.

• Quality control involves monitoring and testing products or services to identify any defects or deviations from standards.

• It aims to prevent defects or errors from occurring and to ensure consistent quality throughout the production or service delivery process.

• Quality control includes activities such as inspections, sampling, testing, and documentation.

• It may involve the u...read more

Requirements for flavours in regulatory affairs include safety assessments, compliance with regulations, and accurate labeling.

• Flavours must be safe for consumption and not pose any health risks.

• Regulatory agencies may have specific guidelines for the use of flavours in certain products.

• Accurate labeling of flavours is essential for consumer transparency and safety.

• Examples of regulations include FDA regulations in the US and EFSA regulations in the EU.

Photostability conditions refer to the environmental conditions under which a drug product should be stored to maintain its stability under light exposure.

• Photostability testing is conducted to evaluate the effects of light on a drug product.

• ICH guidelines provide recommendations on photostability testing conditions.

• Factors such as light intensity, wavelength, temperature, and humidity should be considered.

• Examples of photostability conditions include exposure to UV light, fl...read more

The development of new drugs involves extensive research, testing, and regulatory approval processes.

• New drug discovery through research and development

• Preclinical testing for safety and efficacy

• Clinical trials to evaluate effectiveness and side effects

• Regulatory submission and approval process

• Post-market surveillance for monitoring safety and effectiveness

Types of packaging include primary, secondary, and tertiary packaging.

• Primary packaging is the immediate container of the product, such as a bottle or blister pack.

• Secondary packaging is used to group primary packages together, like a box or carton.

• Tertiary packaging is used for transportation and storage, such as pallets or shrink wrap.