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Biological Safety Subject Matter Expert (m/w/d)

Date: Jun 7, 2021

Location: Dresden, SN, DE, 01277

Company: Heraeus

[title]
Biological Safety Subject Matter Expert (m/w/d)
Location Dresden
Permanent 
Full Time
 

Imagine a job where you will have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development and support you need to be successful now and in the future. If you want a career without limits with a market-leading family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of approximately 14,900 employees are bringing forward new ideas and solutions that are impacting and transforming everything from healthcare to renewable energy to e-mobility to high-tech and telecommunications.

 
 

Your role and responsibilities:

  • In your role you will be the local and corporate SME to design, execute and interpretate preclinical safety and biocompatibility evaluation strategies and programs according to relevant regulatory requirements; including biological risk assessments and execution of required studies and particulate studies
  • You have a high interest in the planning, execution and management of biological risk assessments as well as studies for the safety and biocompatibility characterization of novel and existing products
  • You will support projects and clients locally and corporate during the process of selecting proper materials with respect to biological safety during design development phase, as well for material changes in post-production phase
  • In your role you will support projects and clients locally and corporate-wise for the particulate evaluation of medical devices  and you support regulatory submissions, project teams, and manufacturing;
  • During internal and external audits you are the subject matter expert.
  • You will act as an internal trainer for the above-mentioned areas and in the future you can supervise team members, identify development opportunities, create and implement training and educational plans.
     

What is required for this role:

  • PhD degree in Biotechnology/Microbiology/Bioengineering, preferably having interdisciplinary experience in Material Science or Chemistry
  • You bring at least 3 years experience in a regulated industry in a similar role
  • You understand the ISO 13485, MDR 2017/745 and 21 CFR part 820 and related requirements
  • You communicate excellent (written and spoken) in English, German language skills would be beneficial
  • Within a growing organization leadership or team lead experience is preferred.
  • An independent and autonomous working style supports your success in fulfilling your tasks and handling the support for multiple projects and products.