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Job: Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Contract Type: Permanent
Location: Birmingham
Sector:
Salary: Competitive salary in line with experience
Start Date: 2017-10-09
REF: RASB
Contact Name: Tanya Zero
Job Published: 10 months ago

Job Description

My client has over 25 years expertise in the research, development, manufacture, and sale of innovative medical diagnostic products & instrumentation that are focused on Multiple Myeloma and other Immune system disorders. They provide clinicians and laboratory staff with the tools to improve the diagnosis and management of patients across a range of immune system disorders. They are now seeking a Regulatory Affairs Specialist to join their established team.

The role will require you to carry out global product registrations while ensuring compliance with the relevant regulations. You will need to offer general advice on regulatory strategy for new products and product changes. You will also be required to take part in both CE marking & post market surveillance activities. Direct liaison with regulatory agencies will also be an aspect of the role as will the development of regulatory policies, procedures & specifications across the business and ensure they are compliant with the Quality Systems.

 

Key Qualifications/Experience needed include:
  • Knowledge of Global Regulations
  • Knowledge of GMPS/ISO 13485
  • A scientific, medical or engineering background with a degree or equivalent and/or 2-5 years regulatory experience.
 

To apply please send your CV to tanya.z.a4lglnnuoxh@monarch.aptrack.co.ukering and successful applicants will be contacted within 7 days.