Description
Toxicology Team Lead, MDR, Medical Device
Job Description
As a Team Leader reporting to the Director of Toxicology based in the Research Centre your major responsibility will be to lead the Toxicology team and support programs to address biocompatibility and preclinical safety of all products intended for registration and market by preparing, reviewing and submitting various business specific change documentation. You'll be tasked with overseeing projects and programs and assist with hiring, developing and managing the Toxicology team.
Other key features of the role include:
- Supporting of gap assessment related to European Union Medical Device Regulation (MDR).
- Overseeing operational activities, including review and processing of ACR submissions/change documentation.
- Assisting and supporting with the development of documentation, summaries and interpretation of preclinical evaluations as required for regulatory registration and compliance, and support of product marketing.
- Contributing to design, execution and interpretation of preclinical, biocompatibility, chemistry and toxicological evaluation programs
- Coordinating laboratory and sponsor activities.
- Managing MDR gap assessment and document preparation, including Biological Evaluation Reports (BERs).
- Participating on Project Core Teams as an SME, providing Biocompatibility and other CPDT related input as necessary.
- Conducting risk assessments and reviewing risk assessments conducted by others to assure patent safety and to minimize corporate risk.
With a BA/MA or PhD degree in toxicology or a related field you certainly have 5-10 years of pre-clinical experience. With a good level of educational achievement, you have a broad background in biology, toxicology and chemistry including familiarity with recent methodologies and evaluation techniques (ISO 10993).
You'll also bring:
- Experience from an FDA or EU regulated medical device setting
- Ability to communicate and work effectively across a wide national and international, internal and external client base.
- Ability to multitask and operate effectively within a diverse work environment
- Team oriented mindset, strong interpersonal skills and customer focus
- Excellent scientific written and verbal communication skills