Hi,

I am having an interview for Regulatory Affairs Manager. Can I get advise how to prepare for this interview ? What reading should I be doing ?

:thanks:

:topic: Do you know what the 'speed reader' in me interpret at the first glance of the heading?

Regular (having) Affairs Manager :lol: :lol:

Hi,

I am having an interview for Regulatory Affairs Manager. Can I get advise how to prepare for this interview ? What reading should I be doing ?

:thanks:

have they given you a job description that you can share with us?

Hi,

I am having an interview for Regulatory Affairs Manager. Can I get advise how to prepare for this interview ? What reading should I be doing ?

:thanks:

What industry are you in?

have they given you a job description that you can share with us?

I do not have a soft copy but am offered a hard copy. It states the following, besides some general info -

1. Generate DMR, DHF, qualification and validation documentation
2. Ensure Compliance to FDA requirements like 21 CFR Parts 210, 211, 820
3. Ensure Compliance to ISO 13485
4. Customer Interface with respect to customer audits and presentations
5. Ensure that all CAPA are resolved satisfactorily and in a timely manner.
6. Training people on all regulatory aspects
7. Define quality system compliant to FDA, Canadian, Japan, EU regulations
8. Perform internal audits to ensure compliance to above.

:topic: Do you know what the 'speed reader' in me interpret at the first glance of the heading?

Regular (having) Affairs Manager :lol: :lol:

or REGULARLY HAVING AFFAIRS MANAGER ;)

I do not have a soft copy but am offered a hard copy. It states the following, besides some general info -

1. Generate DMR, DHF, qualification and validation documentation
2. Ensure Compliance to FDA requirements like 21 CFR Parts 210, 211, 820
3. Ensure Compliance to ISO 13485
4. Customer Interface with respect to customer audits and presentations
5. Ensure that all CAPA are resolved satisfactorily and in a timely manner.
6. Training people on all regulatory aspects
7. Define quality system compliant to FDA, Canadian, Japan, EU regulations
8. Perform internal audits to ensure compliance to above.

The list you provided can definately provide hours and hours of enjoyable reading.;)

The FDA, MDD and ISO 13485 should be known inside and out.

Hi,

I am having an interview for Regulatory Affairs Manager. Can I get advise how to prepare for this interview ? What reading should I be doing ?

:thanks:

I would suggest Hemingway, Faulkner and Thurber. If you aren't already qualified for the job, reading isn't going to help.

I would suggest Hemingway, Faulkner and Thurber. If you aren't already qualified for the job, reading isn't going to help.

Jim, I know most of the stuff but I wanted to have thoughts from the cove members so that it could be a "CROWN" on my head

:bigwave:

I would suggest Hemingway, Faulkner and Thurber. If you aren't already qualified for the job, reading isn't going to help.

Jim, I was thinking the exact same thing.

Stepping into a RA Manager position in a medical device company will be a haunting task if you are not prepared for the job.

I do not have a soft copy but am offered a hard copy. It states the following, besides some general info -

1. Generate DMR, DHF, qualification and validation documentation
2. Ensure Compliance to FDA requirements like 21 CFR Parts 210, 211, 820
3. Ensure Compliance to ISO 13485
4. Customer Interface with respect to customer audits and presentations
5. Ensure that all CAPA are resolved satisfactorily and in a timely manner.
6. Training people on all regulatory aspects
7. Define quality system compliant to FDA, Canadian, Japan, EU regulations
8. Perform internal audits to ensure compliance to above.


Review the things you have done for the past ten years.
1. Have (redacted) cover letters (introductory letters to the FDA) available from submissions you have prepared or coordinated and be able to speak to them. Including IDEs, 510k, and PMA.
2. Be able to speak to design dossiers and technical files you have put together or coordinated.
3. Be able to speak to the different types of product and their regulatory classifications.
4. Re-read the standards if you need to.
5. Have presentations available for the training you have given on the regulations above.
6. Be able to speak to complaint regulations for item 7 above, including concrete examples of complaints, related corrective actions and investigations, and recallls or market corrections you have coordinated.
7. Be able to clearly state the differences betweeen auditing for ISO 13485 and 21 CFR 820 including the relative importance of complaints, reporting, and validation.
8. Be able to clearly state the training you have in auditing, the training you have given others, and and certifications you hold.

That is what I would expect an interviewee to be able to do for this job. Reading will not prepare you for the position or get you the job, concrete examples of your application of the principles will.

Hope that helps, and good luck!

Jim, I know most of the stuff but I wanted to have thoughts from the cove members so that it could be a "CROWN" on my head

:bigwave:

I didn't think that there were regulations in China.:cool: Just joking.

Late to the party. :o:D

But just for any future readers' benefit.


Interestingly that job description is more than a Regulatory Affairs Manager's role. It is a Quality Assurance and Regulatory Affairs role.

Nothing wrong with that, many small/medium medical device companies have a single person covering both responsibilities.

But they are different.