Regulatory Affairs Manager-100% Remote Working


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

25th June 2020

Location

Republic Of Ireland

Salary/Rate

£54216 - £58734

Type

Permanent

Start Date

ASAP

This job has now expired please search on the home page to find live IT Jobs.

I'm currently working with one of the most dynamic regulatory consultancy firms in Europe and who work with some of the biggest names in medical device and clinical trials daily. They currently have an opening for a RA Manager to join their team.What will I be doing as RA Manager ?Management of medical device team membersOwnership/ regulatory responsibility for a portfolio of products for the nominated client and be responsible for close liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with time frames.Review of clinical literature and preparation of Clinical Evaluation Reports.Assessment of product complaints to determine vigilance responsibility according to guidelines.Builds and maintains strong relationships with EU Health Authorities as appropriate to ensure ease of access.Works collaboratively with other department colleagues to share best practice and informationManagement / review of Non-conformance'sPreparation of Annual Product Reviews and generate documents as necessary for management reviewWhat do I need to be a RA Manager ?Minimum or related primary degree.Minimum of 3/4 years' experience within Regulatory Affairs or Compliance in a Medical Device EnvironmentBe an authority on EU Medical Device Directives, the upcoming MDR and be able to provide support as necessaryStrong commercial awareness and an ability to assess the commercial implications of decisions and advice.Excellent written and oral communicationAbility to project manage across a diverse and complex portfolio of products andAbility to get on with people, to influence people both internally and externally and to achieveAttention to detail and solid interpersonal, communication and organisational skills This is an excellent opportunity to lead and grow a team of medical device experts on a wide variety of projects. The role offers the opportunity to develop your career (while working remotely) and to lead a team of medical device regulatory experts. If you'd like to discuss the chance of becoming Regulatory Affairs Manager , please send across your current CV and we can have a confidential conversation about this opportunity. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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