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Global Regulatory Affairs Health Senior Associate (Medical Devices)

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Job Title: Global Regulatory Affairs Health Senior Associate (Medical Devices)

Want to steer the growth of a major global brand? As a Global Regulatory Affairs Health Senior Associate (Medical Devices) you’ll have the freedom to show us what’s possible and help drive innovation that makes an impact. Globally.
 
Global Regulatory Affairs Health Senior Associate (Medical Devices)
Kingston upon Hull, East Yorkshire
Competitive Salary & excellent benefits package
 
 
The Senior Associate role plays an essential role in driving and promoting the processes and steps that are followed during the creation and delivery of “right first time” dossiers across the Health brands for medical devices. You will review and advise on the dossier scorecard process, driving consistency and provide support to the Global Regulatory Health teams in the medical device dossier creation process and/or variations to existing dossiers, and the tools and techniques used.  Support the Global Regulatory Health Senior Manager Medical Devices providing adhoc advice & support with regards to medical device dossier compliance, Dossier Content Plan and approval of Dossier Scorecards. Collaborate with the Global Regulatory Health teams to help define and mitigate key risks identified on any data proposed for inclusion in the dossier and to provide guidance on timings for the preparation of medical device dossier sections. From internal/external audit learnings and working in partnership with the Regulatory Intelligence team you will assess regulatory changes impacting the content the medical device dossier and ensure that future developments and existing products take account of these. Provide SME input into the creation of new and review of existing Global Regulatory Health Policy, SOPs, guidance and associated training materials for medical devices. Support the Global Regulatory Health Senior Manager Medical Devices in developing and implementing a training roadmap and programme to drive operational excellence across the Global Regulatory Health teams incorporating new medical device legislation/regulation requirements and industry best practices as required. Provide support and facilitate during medical device external audits and audits undertaken on Regulatory teams internally to ensure consistence and drive improvements.

 

You’ll succeed because… 
…you’ve a scientific background and an understanding of Regulatory Affairs (Medical Devices). You know new product development, registration and submission processes. You’ve close attention to detail in preparing technical dossiers, variations and renewals. You’re an excellent communicator, influencing others to make fact-based decisions. You’re results-orientated, are willing to take the lead in challenging situations and are always looking to make things better. Like us.
 
You’ll love it because… 
…you’ll get to make an impact like never before. You’ll be responsible for your own projects - we can’t wait to hear your ideas. The products you help us get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you.
 

Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Job Segment: Medical, Medical Device, Healthcare

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