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Regulatory Compliance Manager - Quality Systems Manager

  • Job type: Permanent
  • Location: Brussels
  • Salary: Competitive
  • Job reference: RA Manager
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 06/12/2017
Regulatory Compliance Manager

An international leader in medical imaging software and diagnostic development is seeking an experienced Regulatory Compliance Manager for their site in Brussels, Belgium. This Regulatory Compliance Manager will join the Quality/Regulatory Affairs department, with a specific focus on the Breast Health and Surgical department. This will person will be the QMS manager and will be responsible for QMS audits and Distribution Systems. Working with a multifunctional project team, currently including 1 Regulatory Affairs Director and a VP of Quality and Regulatory – they’ll be reporting to the VP of Quality and Regulatory Affairs and will have 2 direct reports. The Regulatory Compliance Manager will deal with all distributors and dealers, working on the integration of newly acquired distributors. They will br building sa function from early-staged processes and harmonising events across multiple companies. 

Company Overview

The company is a respected member of the software diagnostic device world, specialising in delivering innovative solutions that integrate tissue diagnostics with software, whilst also offering client consultation services. The company prides itself on the quality of their software, and their engaged culture, which stems from their passion for helping diagnose and ultimately defeat cancer.

Responsibilities

  • Apply existing regulations to ensure compliance with existing EMEA/Canadian regulations
  • Have full responsibility for audit programmes in accordance with quality compliance team
  • Participate in global quality compliance teams and support implementation of harmonized procedures.
  • Ensure adherence to the company quality audit schedule in international sites.
  • Report to regional and international management on the status of all audits.
  • Interface with company employees, dealers and distributors regarding quality compliance activities.
  • Interact with regulatory agencies in regards to audits and responses until closure.

Requirements:
  • Bachelor’s degree in physical/biological sciences or engineering preferred
  • Expertise in standards and regulations for medical devices as ISO 13485, IEC 62304, IEC 62366, ISO 14971, CFR Part 820
  • QMS and Audit Expertise 
  • Good distribution Practice

Package:
  • Competitive benefits and great personal development opportunities
  • Work in the Brussels
  • Great atmosphere within a vibrant and international team
  • A modern and creative working environment
  • Insight into cutting-edge technologies for the successful development of diagnostics

 

Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: apply.a33ho1gkg3r@epmscientific.aptrack.co.uk or phone +442037588934
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