Register for Postdocs & Researchers - Key2COMPLIANCE- VT23

key2COMPLIANCE 

Note that key2COMPLIANCE is looking for researchers for two different projects. State the name of the project that you would like to apply to on your Cover Letter.

Target group: Postdocs and researchers (3 months)

About the organization

Key2Compliance is a life science consultant and training company. We offer consultant services for medical device companies within four business areas: Regulatory Affairs, Quality Assurance, Biological Safety and Clinical Development. For Pharmaceutical companies we currently offer quality assurance consultant services. Key2Compliance also offers extensive training services in regulatory matters and quality systems for both Pharmaceuticals and Medical Device products throughout the full product life cycle.

The project will take place in the clinical developments business area in the team focusing on clinical/performance evaluation of medical devices. This group consist of seven consultants and a manager. The main focus of the team is to perform clinical/performance evaluations of medical devices, which is needed for all types of medical devices.

Project Clinical/Performance Evaluation

The project will take place in the clinical developments business area in the team focusing on clinical/performance evaluation of medical devices. This group consist of seven consultants and a manager. The main focus of the team is to perform clinical/performance evaluations of medical devices, which is needed for all types of medical devices.

The project

The project will focus on helping our customers with performing clinical/performance evaluation and typically consist of several parts such as planning the evaluation based on the characteristics of the medical device, performing literature searches and a literature review, collecting and reviewing clinical (such as clinical investigations) and other data from the customer, analysis and appraisal of data and finally document and draw conclusion in a report. The evaluation is performed according to the applicable regulations and guidelines.

The project will be done together with the consultants in the team and focus on that the candidate get to try out the different parts of the evaluation, get to know the regulations and guidelines, working with the applicable internal processes and templates that we have in the team.

We can guarantee that this is a learning experience!.

Location: The candidate will be located in Stockholm, in the office in Skeppsbron, Gamla Stan.

Time period: The optimal time to start is in the middle/end  of August 2023 and then full time for three months.

The candidate

The candidate has a PhD in life science, preferably in Medical or Biomedical science. To be able to succeed in the project a skill for medical writing is required as well as ability to work in a team environment.

Contact information

Name: Johanna Fugelstad

Email: johanna.fugelstad@key2compliance.com

Telephone: +46 725 099 176
Company website: www.key2compliance.com

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Project Biological Safety

The main focus of the Biological Safety team is biological and toxicological evaluation of medical devices according to applicable regulations and guidelines. This evaluation is needed for all medical devices in direct or indirect contact with the patient and/or user. The team also provide other services related to pre-clinical safety of medical devices, and services related to laboratory-based quality management systems such as Good Laboratory Practice (GLP) or ISO/IEC 17025. The team also help clients evaluate the analytical performance (e.g. sensitivity, specificity, linearity) of in-vitro diagnostic devices.

The project

The candidate will be involved in and supporting the team’s regular activities towards clients, the exact projects will depend on both the candidate’s background/knowledge/interests, as well as the projects ongoing at the time period of the internship. We can guarantee that this is a learning experience!

Location: Stockholm (office in Gamla Stan), Göteborg or Lund (responding to Director in Göteborg), but work can to a large extent be performed remotely.

Time period: suggested 3 months full time starting Sept 2023

The candidate

The candidate should preferably have a background in Toxicology, Material science and/or Analytical chemistry and an interest in medical devices or in vitro diagnostic devices. Laboratory experience (in chemico/in vitro/in vivo or using diagnostic kits) is also appreciated. Strong skills in scientific writing and argumentation is needed.

Contact information

Name: Emma Pedersen                        

Email: emma.pedersen@key2compliance.com      

Telephone: +46 70 561 02 11
Company website: www.key2compliance.com