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1 Key Tip to Nailing your Regulatory Affairs Job Interview

By Andrew Ahn posted 18-Nov-2014 03:58

  


This post was originally published on www.regdy.com.  


This isn’t your average interview, this is a Regulatory Affairs interview.
If you have a face interview lined up, the following probably already happened:

1. You survived the weeding process. The recruiters checked your work history on your resume, your Linkedin, and searched the FDA 510(k) database to see how many 510(k)s you were involved in. I know that many folks are frustrated with the 510(k) numbers game because anyone who worked in the industry knows that many hands touch the 510(k) but there’s only room for a primary/secondary author on the 510(k) summary. Regardless, congratulations, you are going to Hollywood!..or the burbs where most of the medical device manufacturing plants are located.

2. You also most likely passed the phone screen interview. I know you’d like to think it was all due to your regulatory prowess and dazzling charm but after your celebratory dance, simmer down and take a deep breath. Now understand that factors like the number of applicants in your region and your salary range history played a role in landing the face to face interview. If you know that not a lot of people can do what you do in the area, you have more leverage…more ammo for negotiations.

Now what everyone clicked on this article to find out…

The 1 Key Tip that will help you get that offer letter, signed sealed and delivered is…to be Relevant.

Be relevant to the products that they manufacture. Recruiters usually just look for basic RA experience statistics but they seldom focus on the repertoire of products that you have experience in. Even if they do, recruiters don’t really work with the products intimately to know what to ask. In addition, your resume might not comprehensively cover all the products you have worked with.

RA folks are usually working in a NICHE BUSINESS UNIT (i.e. Diabetes Monitoring). You know how to think in Regulatory, but you also know that different product types have a myriad of Guidances and Standards associated with them. If you don’t have that specific product type under your belt, leverage the common thread between the devices you worked with and the devices that the interviewing company manufactures. If you worked with devices that have a software component, that skill set can directly be applied to devices like Mobile Apps and PACS systems. Talk about how you addressed those specific pain points related to that type of device.  Discuss things that fulfill the employer's needs, not yours.  

Also, be relevant to the Subject Matter Expert(SME) that is interviewing you. Look at the interview schedule provided to you beforehand and do a little bit of research on the interviewers. You will probably have 2- 6 people interviewing you at different time slots. The interview panel may consist of Quality Assurance, Regulatory Affairs, Engineering, Operations, Marketing, and perhaps the General Manager depending on the level of the position. Talk about relevant issues to the SME’s function. Engineers might be engaged in design control activities and standards. Marketing may be more interested in claims that can be made for a device and approval timelines. Cater to the demographic and be relevant.

Common grounds creates bonds and builds rapport.  It seals the deal.

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