Head of Quality Assurance

A bit about the company and what they can offer you
Our client develops, produces and sells a highly advanced product portfolio for the treatment of visual impairment and corneal diseases. The medium-sized company with more than 200 employees is one of the technology leaders for eye lasers for refractive and therapeutic corneal surgery and is present with its products in more than 100 countries. You can expect an excellent benefits package to reward your hard work, which involves a generous holiday allowance, free drinks, fruit and canteen use, a monthly benefits card and much more!
  
What you’ll be doing 
As Head of Quality Assurance, you will collaborate with cross-functional teams to monitor product quality at every stage. Whilst holding responsibility for international registration and re-registration projects for active and sterile medical devices, through planning and implementation of complex international registration projects with local partners/distributors.

Your day to day might look a little like this:

• Compilation of submission documents for registration activities
• Participation in the development of international approval strategies for active medical devices and coordination with our R&D team
• Ensuring continued compliance for currently marketed products
• Participation in amendment requests on approval-relevant topics and review of normative and regulatory requirements (also international)
• Review of internal documents (e.g. labels, advertising materials, training materials)
• Continuous support of project teams on regulatory issues, especially during the development phase
• Reviewing changes in the regulatory environment and communicating relevant changes to the company to ensure continuous compliance
• Establish procedures and internal standards as required (e.g. SOPs, work instructions, forms and checklists)
• Organisation of internal and external audits

A bit about you
Ideally, you’ll be based in Germany.

You’ll have 3+ years of relevant professional experience within medical devices. 

A few other key skills our client is looking for:

• Studies in engineering, medical technology, medical informatics or a related field
• Experience in the certification and international registration of active or sterile medical devices and in the compilation of regulatory dossiers
• Experience in the development of active medical devices or software development
• Knowledge of EU, US and global regulations on medical devices
• Knowledge of relevant standards and associated test procedures such as IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2, IEC 60601-1-6, IEC 60825, IEC 62304, as well as the corresponding specifications for sterile medical devices
• Experience working in multidisciplinary and international project teams
• Excellent organizational, communication and negotiation skills

Want to hear more?
If this role has sparked your interest, get in touch with Adam Leeder (adam.leeder@fmctalent.com). 

If you want more information on what the core duties are for this role, we can send the job description your way! 

A few more details
Reference number: 18662
Temporary or Permanent Position: Permanent
FMC Talent