| 16 |
Describe an experience when you reviewed product promotional materials, labeling, batch records, specification sheets, or tested methods for compliance with applicable regulations and policies. |
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| 17 |
What is the most challenging part of coordinating efforts associated with the preparation of regulatory documents or submissions? |
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| 18 |
Tell me about the last time when you prepared or maintained technical files as necessary to obtain and sustain product approval. |
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| 19 |
Share an example when you effectively advised project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. |
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| 20 |
Describe what methods you use to determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. |
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| 21 |
Provide a time when you were able to identify a complex problem, evaluate the options, and implement a solution. How did the solution benefit your employer? |
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| 22 |
Provide a time when you dealt calmly and effectively with a high-stress situation. |
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| 23 |
Share an experience when you coordinated recall or market withdrawal activities. |
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| 24 |
How do you stay up to date on adverse drug reactions and file all related reports in accordance with regulatory agency guidelines? Share an example. |
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| 25 |
Share a time when you willingly took on additional responsibilities or challenges. How did you successfully meet all of the demands of these responsibilities? (Make sure the candidate is a self-starter and can demonstrate some initiative.) |
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| 26 |
Describe an experience when you communicated with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. |
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| 27 |
What have you found to be the best way to escort government inspectors during inspections and provide post-inspection follow-up information as requested? |
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| 28 |
Share an experience in which your understanding of a current or upcoming problem helped your company to respond to the problem. |
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| 29 |
Tell me about the last time you monitored or reviewed information and detected a problem. How did you respond? |
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| 30 |
Describe effective ways to identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance. |
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