Back to search
Our client is one of the world's leading manufacturers of medical devices with a presence in over 100 countries. They have a permanent opportunity for a Senior Scientist - Biocompatibility with a particular focus on Biological Evaluation.
In this role, you will be responsible for generating, maintaining, and updating Biological Evaluation Reports (BERs) per EU MDR requirements.
Responsibilities:
- Compile and deliver biocompatibility assessments and biocompatibility evaluation plans
- Generation and maintenance of Biological Evaluation Reports to meet EU MDR regulations
- Perform and assist with risk assessments and gap analysis of external standards, regulatory requirements, and guidance documents
- Collaborate with cross-functional teams to support projects requiring biocompatibility evaluation
- Keep abreast of regulatory requirements including monitoring EU MDR, FDA and other agency regulations and international standards
- Prepare or collaborate in the preparation of toxicological safety assessments including materials, chemicals, technologies and processes or finished products
- Work within multi-disciplinary teams (notably R&D, HS&E, Import/Export, Supply Chain and RA/QA)
- Ensure due process is followed under R&D Policies
- Support the creation and development of the strategy for biological/toxicological evaluation (including testing requirements) for materials and finished products
- Provide technical support and coaching for members of R&D, regulatory or any other relevant department
- Provide consultancy on technical issues both within R&D and other stakeholders.
Qualifications:
- Either a BSc in a biological science (Pharmacology, Biology, Physiology, Biochemistry or similar) or related discipline (MSc in Toxicology or any work-related experience in toxicology a bonus)
- Industrial experience within the chemical area (Medical device / pharmaceutical preferred)
- Direct experience working with ISO 10993
- Success in leading change in particular for the implementation of ISO 10993 standards
To find out more about Real, please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office |8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales
