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Leader Verification

  • Job type: Permanent
  • Location: Munich
  • Salary: Competitive
  • Job reference: RNMR - 26442
  • Sector: EPM Scientific, Regulatory
  • Date posted: 01/03/2018
Leader Verification 

Due to their exceptional growth trajectory for 2018, an incredible opportunity has arisen for a quality and or regulatory expert within the medical device industry. The successful candidate will be lead on-site customer projects relating to regulatory, quality and verification for the design of medical devices. You will be permanently based from home and then travel to customer sites in order to carry out the verification and testing work. You will also be responsible for a team of verification and test engineers who will also perform on-site verification tasks. You'll be employed permanently, but work on a project basis with various clients, giving you insight into cross functional teams, various high-profile companies and an infinite range of devices. 

Company Overview 

The company is going through an unprecedented period of growth after exceptional success in 2017. The high volume of customers has resulted from repeated success with medical device manufacturers across Germany. The company is a national leader in quality and regulatory process optimisation, in testing and verification and in consulting and service providing for medical device companies. In the current climate, with the MDR and the boom in extra medical device QA/RA work, the company is extremely well positioned to continue on their exceptional growth path throughout 2018. 

Responsibilities 

- Defining and implementing quality and regulatory verification procedures to ensure process optimisation 
- Designing and implementing strategies according to ISO 13485 and ISO 14971 
- Defining risk management approach 
- Collaboration in the approval procedure of the medical device in Europe (CE) and USA (510 (k))
- Preparation of standard operating procedures and work instructions for verification and validation considering ISO 13485, 21 CFR 820 (QSR), ISO 14971 and EN 60601-1-6, IEC 62366 
- System verification testing, responsible for system compliance after engineering changes or defects/complaints

Requirements

ISO 13485 
- ISO 14971 
- 21 CFR 820 
- EN 60601
- IEC 62304
- Medical device testing, verification testing, system verification

Package

- Competitive market salary 
- Travel and accommodation expenses 
- Travel counting as working time 
- Home office 
- Opportunity to work in multiple companies on various devices and projects 
 
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.a33ho1gmpto@epmscientific.aptrack.co.uk or phone +442037588934

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