Regulatory Open Forum

 View Only

  • 1.  Regulatory Department in Organizational Structure

    This message was posted by a user wishing to remain anonymous
    Posted 22-Aug-2023 09:08
    This message was posted by a user wishing to remain anonymous

    Hello,

    My company currently has separate Quality and Regulatory departments but the new CEO wants to put Regulatory under the Quality department. I am trying to convince them this is a bad idea but can't find any regulatory guidance to back me up. Does anyone know of anything I can reference to support my argument or am I wrong?

    Thankls!



  • 2.  RE: Regulatory Department in Organizational Structure

    This message was posted by a user wishing to remain anonymous
    Posted 22-Aug-2023 13:49
    This message was posted by a user wishing to remain anonymous

    Unfortunately there is no regulations (at least in the drug world) or rule that RA cannot be under Quality! However, if this is a drug/biologic company then your CEO is doing this for some specific reason but certainly not a logical or rational thing to do. Perhaps he/she the CEO wants to shake up things because the RA is not performing to his/her liking????? 


    Original Message


  • 3.  RE: Regulatory Department in Organizational Structure

    Posted 23-Aug-2023 03:31

    Anon,

    There is no regulation, standard, or guidance on the organisation structure within a medical device or pharmaceutical company.  This is left completely up to the company and how they want to structure their organisation including where Quality or Regulatory resides within the structure.  Commonly it is understood Quality should be "independent" such as not reporting to Operations, but directly to the CEO/President to allow the independent evaluation, review, and decision making.  In smaller organisations, quality and regulatory are usually in the same functional group.  In larger organisations, regulatory can be part of quality - but this is typically because quality assurance is a larger group in a typical manufacturing company, i.e. quality assurance, quality control, quality engineering, quality compliance, regulatory.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: Regulatory Department in Organizational Structure

    Posted 24-Aug-2023 08:33

    Anon,

    Richard is correct, the only requirement is with regards to quality being independent of operations for the reasons he has cited. I've worked for a variety of companies and they all structure the organization a little differently, but Quality and Regulatory often work closely together regardless of who they report up through.  Both disciplines have interests in ensuring safe products are on the market, maintaining compliance and knowing and following the regulations and requirements.  Looking at your original post, you stated "I am trying to convince them this is a bad idea".  I have to wonder why you think this is a bad idea?  Maybe there is something deeper going on within your company that needs to be addressed rather than the reporting structure, particularly if you are concerned that Quality and Regulatory cannot work under the same department head. Quality and Regulatory should be allies, not adversaries.  



    ------------------------------
    Sara Coon
    Director, Regulatory Affairs
    MN United States
    ------------------------------

    Original Message


  • 5.  RE: Regulatory Department in Organizational Structure

    This message was posted by a user wishing to remain anonymous
    Posted 24-Aug-2023 09:11
    This message was posted by a user wishing to remain anonymous

    Hi there,

    In our medical device company, regulatory is under quality in our organizational structure and it works great. There's the VP and then the various managers for quality teams and the regulatory team. Roles aren't mixed and we can work together to get things done quicker. 


    Original Message


  • 6.  RE: Regulatory Department in Organizational Structure

    Posted 24-Aug-2023 11:51

    Like most things in the regulated industry there are no "one-size-fits-all" answers to this.  What really matters is whether the functions have the necessary autonomy and decision making authority to perform their job functions without undue influence from other groups creating either a real or even apparent conflict of interests.

    No matter how you set up the structure, the key is, as others have stated, to get to a point where people have the correct authority for the jobs that they are expected to be doing and when necessary the team(s) can work together in a manner that does not negatively impact the business because of in-fighting.  If you can find this balance than any structure can (and will) work for you.  



    ------------------------------
    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States
    ------------------------------

    Original Message


Related Content