How is your Regulatory Department structured?

A

Adele

#1
We are currently reviewing the structure of our Regulatory Department and would like to hear peoples pros and cons of how their regulatory team is structured.

We are the head office of a international medical device company. We have
(1) a central regulatory team and (2) a regulatory team supporting each product group.

The regulatory team in the product group are generalists - that is, they support the regulatory work for almost all the countries we sell in. One proposal is too create specialists - team members who specialise in the regulatory work for one country or region. But I am keen to see and hear any other options.

Thanks
 
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GStough

Staff member
Super Moderator
#2
At our corporate office, we have a one-man regulatory team, my boss. I do whatever I can (in terms of regulatory) and try to learn as much as I can from him, but technically, I'm a member of the QA staff (there are 4 of us at corporate in QA, and one more at another manufacturing facility).

Probably not what you wanted to hear, but that's how it is in my world.
 
L

Laurie Anderson

#3
We are an International Medical Device Company as well.

We have a Regulatory/Quality team of two (2). My boss the Regulatory / Quality Manager and myself, Regulatory Affairs and Quality Systems Coordinator.

We market in all regions across the globe, Europe (EU), South Africa, Middle East, Asia, South and North America.

We both deal with Regulatory and Quality although the emphasis is more Regulatory for my boss and more Quality for myself. You cannot really separate or draw a line between the two disciplines as there is an overlap.

Laurie
 
M

MIREGMGR

#4
~300 employee device maker with three plants...two US, one China.

Also operates a Canadian distributor.

Legally structured as three companies. (US = 1, China = 1, Canada = 1.)

Regulatory Department = 1 person (me), the manager. I handle regulatory issues for all companies, working for the US company.

Each of the device making companies also has a Quality Department.

US company: 4 persons.

Chinese company: 3 persons (I think).
 

Ajit Basrur

Staff member
Admin
#5
It depends on the volume of the products handled. In my previous organization, we had a Head overseeing Reg Affairs and one each for different regions viz. Americas, Europe and Asia.
 
A

Adele

#6
Thanks for your replies so far. It is very interesting and helpful to hear from you all.
 
C

Crimson

#7
So, in your opinion, better for a team to be focused on a product, with members specialized in different geographies - or the other way around; a team focused on a geography with members who are product specialists?
 

Ajit Basrur

Staff member
Admin
#8
So, in your opinion, better for a team to be focused on a product, with members specialized in different geographies - or the other way around; a team focused on a geography with members who are product specialists?
I feel its better to focus on geographies as the concerned person would get familiar with the applicable regulations of that country.
 
Z

zhang126

#9
Worked before in an EU medical device company as a reg manager with ~600 employees and sales in 60 countries.

It organized RA as this:
Headoffice: Reg. group 6 manegers, one director, 2 assistants, in which one specilized in Asia (Japan, China, Taiwan, S. Korea ...) as thay are "authority registration" model.
one specilized in N.America (US FDA, Canada etc.)
one specialized in EU MDD as well as othe "Certification and conformity assessment" based regulatory process (many middle east countries as well, as they are satisfied with CE-markt and FSC).
All are required to be able to comply with MDD and 510(k) as basic Reg competence.
All are required to be able to support R&D project with MDD and US regulations. Each R&D project and marketing company or distributor or registration agents has a contact person defined.

Hopefully it helps.
 
M

m4zzy

#10
Hello all.

I work as a develomment designer in medical device company in EU. We don't have any Regulatory department which I think it not good at the moment with all the legislation and stuff.

Usually, when a Notified Body come and does periodic CE audit for device on the market or CE audit for newly developed device, NB will find some findings. We have problems usually with Risk managements, Clinical evaluations, correctly fullfilled checklist of essectioal requirements, standard's updates and so on.

IMHO, preety important stuff for the company. My issue is that if for example Risk management doesn'n comply with ISO 14971:2012, nobody will create a new "template" or "guide" on how to do Risk management. Every time it goes down to our R&D department as "we create the product so you do it yourselves" -> so that means we have to think about how to create new Risk management file, Risk analysis and all the stuff which we have to comply with. That means the R&D is standing still for some. (Some just don't care)

The same goes with Clinical evaluations, Proof of substantial equivalence and so on.

My question is:
Is Regulatory department responsible for setting the system on how the employees will comply with standards (so R&D designers will have a guide for Risk analysis and all rules we have to obey) or is it really on our backs in R&D? In every standard I read "top management has to set the rules".

If not, who usually does that? Quality management?


I am trying to think of a Regulatory Dept. which will set the rules for doing all this stuff, from Risk Management, clinical evaluation, standards and telling R&D dept how to comply with all the legislative and will have the responsibility to set the rules and system for this.

I hope I explained this well.

Thanks for help
 
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