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Global Regulatory Affairs Senior Manager

£Excellent basic salary, car allowance, 20% bonus accelerators, 10% pension, healthcare | Yorkshire & The Humber |  Regulatory Affairs, CRO |  Permanent  | Ref:889965

The Role

Global Regulatory Affairs Senior Manager - Medical Devices - Global Healthcare Company - Yorkshire - £Excellent basic salary, car allowance, 20% bonus accelerators, 10% pension, healthcare, WFH for part of the week

*This company is looking to interview asap, with interviews and the onboarding process conducted remotely**

The Global Regulatory Affairs Senior Manager - Medical Devices will manage a team of 5 Regulatory professionals focusing on a range of consumer medical devices. You'll remain hands on and will be creating dossiers / technical files for a range of medical devices whilst leading the team. You will be the point of contact with the wider business for all regulatory matters for your product portfolio.

 

The Company

My client is a global healthcare company covering multiple therapy areas. Based in Yorkshire, this company have an exciting and broad variety of projects to work on. They've recently opened brand new offices so you will be based in their new state of the art office.

  • Global, leading healthcare company
  • Brand new offices
  • Remote working 2 days per week (once settled into the role)
  • Great career progression

 

The Role

The Regulatory Affairs Senior Manager - Medical Devices will be responsible for managing a complex and diverse set of regulatory requirements across multiple markets.

  • Strategic leadership of global product development and regulatory projects to meet the business objectives
  • Develop and deliver innovative global regulatory strategies in your category
  • Ability to translate complex regulatory information into stakeholder friendly language.
  • Work collaboratively with team in order to define and implement the regulatory strategy &global registration dossiers
  • Manage a small team of 5 Regulatory professionals

 

You

To apply for this role as a Regulatory Affairs Senior Manager - Medical Devices our client is hoping for someone with the following skills and experience;

  • Experienced regulatory professional within medical devices
  • Knowledge of MDD/MDR requirements as well as ISO13485 standards
  • Knowledge in NPD and dossier/technical file creation and global registrations.
  • Extensive experience in medicinal registration across Europe, Russia, Australia/New Zealand and good understanding of ROW medicinal registration and strategy.
  • Strong managerial skills
  • Strong stakeholder management
  • Can work in a fast-paced environment and deliver to strict timescales

 

What should you do next?

This Regulatory Affairs Senior Manager - Medical Devices role is one not to be missed; it encompasses the opportunity to work in a global healthcare company who are at the forefront of their therapy areas. To discuss further, please submit your current CV.

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.

Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

Consultant

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Hayley Shayestehroo

Which team and area do you work/specialise in?

I work in the Regulatory Affairs team and recruit for Regulatory Affairs professionals at all levels within Pharma, Medical Devices companies and Regulatory Consultancies

What are some of the typical roles you cover?

I cover Regulatory Affairs positions at all levels within Pharma, Medical Devices and Regulatory Consultancies, these typically include;

Regulatory Affairs Associate jobs, Regulatory Affairs Executive jobs, Regulatory Affairs Senior Associate jobs, Regulatory Affairs Manager jobs, Regulatory Affairs Senior Manager jobs, Regulatory Affairs Director jobs, Regulatory Affairs Consultant jobs, Regulatory Writer jobs and Medical Writer jobs.

What are the hot issues in your sector currently?

Within Medical Devices it is the transition from MDD to MDR in May 2020. A lot of medical device companies are hiring Regulatory professionals to prepare their company for the transition

What’s makes you #DistinctlyDifferent?

I take pride in getting to know my candidates on a personal level as well as professional. Changing jobs is a big decision for most people so I like to ensure I am placing my candidates in a role that not only matches their career aspirations but also suits their personal situation and key motivations.

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