Biocompatibility Specialist - Oberdorf
Jasmin Baumgartner is recruiting for a Biocompatibility Specialist to join a company in the Medical Device industry at their site based in Oberdorf on a 12 month contract basis.
The main purpose of the role will be to:
- Work alongside site staff to detect and review current Technical File/Design Dossier/ Design History File documentation and the supporting Product, Biocompatibility, Manufacturing Processes, Sterilization, Packaging and/or Cleaning Validation information for MDR transformation.
- Understand and identify possible gaps for ISO 10993-1 and supporting ISO 10993 testing where necessary.
- Be up to date with writing Biocompatibility Protocols and Reports.
Further responsibilities will include:
- Maintaining existing knowledge in current regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, ICH, FDA, etc) and compliance requirements (GLP, departmental SOP's, company policies, etc). Interpret regulations, implement compliance strategies to support the sale of new and existing products, as well as implement procedures in anticipation of regulatory activities.
- Complying with Standard Operating Procedures to ensure compliance with FDA Good Laboratory Practices (21 CFR, Part 58).
- Working under minimal supervision, conduct research and contribute to the origination and direction of experiments and new methodologies. Prioritize tasks according to broad project goals. Provide technical consultation on the implementation of experimental activities.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Medical device knowledge is a requirement, Cardiovascular
- Understanding of MDR regulations including ISO 10993
- Experience with Biochemistry, Analytical Chemistry, Manufacturing and how it is used within Medical Devices
This is an excellent opportunity to join a leading medical device company.
For more information or to apply for this position, please contact Jasmin Baumgartner on 0041 782 516 595 or email firstname.lastname@example.org. Please quote 44901 reference in all correspondence.