Design Control Specialist: STED Writer in R&D

Do you have experience from Regulatory Affairs, R&D or QA focusing on writing STED file content for submission to regulatory authorities? The role is vital in our new R&D team and our new colleague is going to be the spider in the web gathering all our validated data for EU MDR / IVDR purposes.

 

An integral part in our team effort

Our new skilled team consists of our experienced colleagues with deep domain knowledge about our Blood Gas Analyzers and syringes. Furthermore, the team has strong capabilities within Design Control and documenting product design changes. To keep our project timeline for the EU MDR / IVDR legislation we are convinced that you will experience a helpful and effective team effort as one of our main authors for our STED submission.

 

Responsibilities

  • Compile input from the R&D organization and put it into the summary file (STED)
  • Write and formulate chapters in STED file.
  • Deliver to notified body on time within 1st year of employment
  • Secure right quality level for submission to authorities

 

Collaboration is key when colleagues deliver input that will be the jump off point for compiling a summary. Technically, it is important to understand the different documentation and the expectations from the regulatory authorities. Our main objective is to make sure there are no gaps in our current documentation.

 

Qualifications

You most like have an educational background as Cand.Scient, chemistry, biology or Engineering combined with most of the following experiences:

  • Experience with regulatory submissions (STED file writing)
  • Solid MDR / IVDR experience and understanding
  • ISO 13485 experience
  • Design Control capabilities
  • Good writing skills and overview

 

Which department you have worked in before is not essential. What is important is that you enjoy the dynamics of working together with colleagues, coaching them on the input they provide and take ownership for securing the quality of the documentation.

 

Radiometer offers

An outstanding opportunity to work with people, who are passionate about making a difference for healthcare professionals. We offer benefits such as a good culture related to working from home, competitive salary and reward frameworks along with plenty of learning and development opportunities. We are among other things known for our DBS toolbox and the many benefits our employees have from mastering these skills.

 

We have no doubt that you can learn and grow in the setup ahead of concluding our project successfully in May 2022. Afterwards the skills and knowledge will be invaluable assets for future equally important strategic projects in our organization. When that time comes, we are excited about utilizing your acquired skills in these projects.

 

Recruitment Timeline

Please apply online as soon as possible. We are recruiting a big volume of employees and expect to identify candidates for interviews continuously throughout September and October. We look forward to hearing from you.

 

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.


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