Eckhard Jokisch The regulation doesn't say anything about the position so it is up to your organization explicitly.
But the sub clauses 2 and 3 describe rather clear which responsibilities and powers this (or those) person(s) shall have.
The persons have a huge responsibility and thus must have real power to start or stop things.
From what I know from other companies those persons are more a director of QA/RA or at least team lead in QA/RA.
Hope this shed some light for you?

Mark Proulx, CQA, cSSBB Begoña Gil IT's been my experience that when the Agency sits with the company before an audit to talk to the staff and collect business cards, they then will ask what your background and experience is to determine whether you are qualified to be in the position you hold. Knowing that each employee holds a certain amount of credibility is key to getting the FDA on board with your program and trusting that you meet 21 CFR 820-25, Personnel. This will inevitably lead to the FDA questioning your entire QMS if they find a lacking in expertise. You have people with engineering backgrounds as engineers, you have people with manufacturing experience in charge of manufacturing, you have CQA's performing internal audits...it only stands to reason that you should have someone with a regulatory background as your regulatory interface with the FDA.

Mark Plait Personally, I'm of the opinion that director level is too low on the totem pole and
this individual should be at least at a VP level. Remember that the person
ultimately responsible is going to be the CEO. If the problem is severe enough
the FDA will ultimately go after the CEO. So it stands to reason that the QA
responsible person needs to be at a VP level with access to the CEO.

Begoña Gil Thanks Eckhard!

Timo, hope all you are doing well!!

To add to what Eckhard says: The Responsible Person should have their role, responsibilities and AUTHORITY spelt out in a Job Description or other official document.

Eckhard Jokisch Although not explicitly by Behona Gil, I assumed that this is about the upcoming MDR in Europe. So all is a bit different than under 21CFR820 - at least what we know about the MDR now.
Under the MDR a QMS according to CS (common sense) is mandatory.
In ISO-13485:2016, clause 5. there are a lot of requirements and responsibilities for the top management - 124 to be precise - and this of course must be documented.

James Shore I went through this document and couldn't find the change you mentioned:
https://www.emergogroup.com/sites/default/files/europe-medical-device-regulation-consolidated-negotiated-text.pdf

Robert Christensen I hope the corrupt attacks of the FDA on medical device companies in America is over

Eckhard Jokisch James Shore: it's on page 62

Joseph Nguyen Antje Marquardsen