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Job Details

Head of Regulatory Affairs | Medical Devices | IVD Products

Company: RBW Consulting
Location: North East England
Reference: LB/HORA/NE/0001
Closing Date: 10 Feb 19
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits: Standard

Job Summary:

A global IVD company are seeking a Head of Regulatory Affairs [READ ON]...

Requirements:

What is your aspiration for your next move?  Is it a company that offers you development in your strategy and leadership role?  Maybe it is a company that can offer you a globally facing role instead?  Perhaps, even a company that could pay you a good salary, whilst also knowing you are doing a fantastic job for someone, somewhere that really needs it?

Well forget that.  Not because your aspirations don’t matter, but because the client I am with, can offer it all.

Based out of their company head quarters in the North East, this global IVD business (Invitro Diagnostics) are looking for their new Head of Regulatory Affairs.

This role is the most senior position within the Regulatory Affairs department and sees the QA and RA managers collaborating closely with this position. Your oversight covers all global offices including North and South America as well as Europe.

 

So, what does the role involve?

  • Being a leader and a strategist.  Working closely with the QA and RA directors mentioned before, as well as the senior leadership team to make sure that the regulatory operating plans align with the company business objectives as a whole
  • Be the stakeholders voice and ear, and alert them of potential risks and mitigated actions in line with the regulatory operating plans
  • Direct your RA team in all areas of their work
  • Provide guidance to the RA team as needed and to cross functional teams when required
  • Manage your team to the point where they can act, almost, autonomously and do the submissions as required (continue this whilst growing out your team and hiring on new people)
  • Define a regulatory pathway for new products being developed and for existing product modifications.  This included developing a Regulatory Operating Plan and scheduling submissions to the FDA and other regulatory agency guidelines.

 

This company are at a critical point of expansion, and they are looking to continue this by implementing even more growth this New Year.  They, therefore, want to make sure that this individual is the right fit for the business, for that reason, they need to meet the following criteria to be considered:

  • Valid UK working VISA (No sponsorship is available from this company)
  • Master’s degree or a PhD in a related scientific subject (An additional qualification in a regulatory discipline would be desirable)
  • Experience working with IVDDs and IVDRs (particularly having carried out registrations in the US and China as well as the EU)
  • A good understanding of therapy area specific devices such as autoimmune, infectious disease, allergy and specialty endocrinology devices.

 

 

In return, this remarkable business will give you:

  • A highly competitive salary
  • A very strong compensation package
  • A true senior management role with an ethical and growing company
  • Global remit over their international regulatory teams

… and much more as well.

 

If you are interested in a position like this, and you would like to find out about the company’s compensation package and more about the role that you would be doing, then APPLY NOW for a confidential conversation.

 

Apply for this job: Head of Regulatory Affairs | Medical Devices | IVD Products

Contact Information:

Address:  Brighton
Southdown House, 130a Western Road, Brighton BN1 2LA
BN1 2LA
England
Tel:  01293 584 300

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