Accessibility Links

Senior QARA Director- MEDICAL DEVICES

  • Job type: Permanent
  • Location: Eindhoven
  • Salary: £100000 per annum
  • Job reference: Jordan Veglio
  • Sector: Medical Affairs, EPM Scientific
  • Date posted: 23/02/2018
Are you an experienced professional in the area of QA/RA in Medical Devices? Are you passionate about QA/RA and Medical Devices? If so, my client has a unique opportunity in our QA/RA department that might be your next challenge.


We offer you a varied and challenging role as a leader of our enthusiastic Quality Assurance and Regulatory Affairs team with a strong international orientation. At my client, we are committed to improve people’s lives and to contribute to a better society. Values you can relate to on a personal level. My client’s commitment to Quality and Compliance is what differentiates us from other companies, therefore we continuously challenge ourselves to improve our products and compliance.




As our QA/RA Manager, you oversee, supervise and manage the QA/RA activities related to all products and processes of my client. You will be responsible for the development, execution and maintenance of Quality Management Systems affecting the overall compliance, sales, distribution, design and manufacturing of OHE products and services in the EMEA. You recommend, coordinate and support the positions, responses and action plans to implement and ensure compliance to current and new regulatory developments.


Your main responsibilities as QA/RA Director
  • Manage and control the QA/RA team, including recruitment, training and performance evaluations
  • Manage and control all activities related the company’s Quality Management Systems
  • Manage and control all activities related to medical claims review and approval
  • Manage Product Documentation and Product labeling review and approval
  • Manage sub-contracting contract review
  • Manage Quality Assurance activities related to Incoming Inspection
  • Manage customer complaints, including nature/cause/ effect analysis and CAPA management
  • Manage the supplier’s production quality control and regulatory compliance improvement programs
What makes you a strong candidate?


Your Skills and Experience in a nutshell
  • University degree in a relevant field
  • Experience in an international medical devices organisation
  • In depth Knowledge of and practical experience regarding the implementation of Quality Management systems ISO 13485
  • In depth Knowledge of and practical experience regarding the implementation and maintenance the Medical Device Directive EEC 93/42 and the Medical Device Regulations (EU) 2017/745,
  • Knowledge of and practical experience regarding technical testing process of medical devices
  • Knowledge of and practical experience regarding Production Quality & Process Validation
  • Knowledge of and practical experience regarding clinical validation and testing of medical devices
  • Proficient in the English language, both written and verbal
Client’s #core competencies
  • Transparent
  • Entrepreneurial
  • Passionate about customers
  • Making it happen
  • Total team player
  • Thorough
 
If interested, please send your CV to apply.a33ho1gmhwe@epmscientific.aptrack.co.uk 

Similar jobs
Sr. Director of Biostatistics
  • Job type: Permanent
  • Location: New Jersey
  • Salary: $180000 - $220000 per annum, Benefits: Comprehensive Bonus Package
  • Description Sr. Director of Biostatistics | FDA Experience Submission| Clinical trials I-IV | Various therapeutic areas   Greater New York
Senior Medical Writer (Remote) - Medical Communications
  • Job type: Permanent
  • Location: Philadelphia
  • Salary: Competitive
  • Description Summary of Job: A top tier Medical Communications agency focused on publication planning is looking for a Senior Medical Writer to join the team as...
Medical Director
  • Job type: Permanent
  • Location: New York
  • Salary: Competitive
  • Description  I.     Position Summary            As the Medical Director, you provide exemplary overall accountability for all medical/scientific aspects of assigned
Manager, Biostatistics
  • Job type: Permanent
  • Location: Basking Ridge
  • Salary: $140000 - $170000 per annum, Benefits: complete benefits package + bonus
  • Description My client is a growing pharmaceutical company with a global presence. They are actively looking to build out their Biometrics group and are seeking two...