
Preclinical Principal Scientist
- Uppsala
- Tillfälligt
- Heltid
- A hybrid work model with flexible hours
- Continuous learning & career development opportunities
- A diverse, inclusive, and collaborative culture
- A modern workplace just 10 minutes from Uppsala Central Station
- Define biological risks and shape preclinical strategy for injectable medical devices
- Design, coordinate and interpret preclinical safety and biocompatibility studies
- Ensure compliance with ISO 10993 series, FDA guidance, EU MDR and global regulations
- Write, review, and deliver high-quality scientific documentation: protocols, reports, and regulatory submissions (e.g., IDE, 510(k), CE marking)
- Act as preclinical lead in cross-functional projects and external collaborations
- Contribute to risk assessments per ISO 14971 and biological evaluations per ISO 10993-1
- Monitor scientific and regulatory developments in biomaterials and injectables
- Ph.D. (or equivalent) in Biomedical Sciences, Toxicology, Pharmacology, Bioengineering or similar
- 6-10 years of experience in preclinical development of medical devices, preferably injectables
- Proven expertise in ISO 10993, GLP, EU MDR, and FDA regulatory requirements
- Strong background in biocompatibility testing and toxicological risk assessment
- Experience managing CROs and outsourced preclinical studies
- Excellent scientific writing and communication skills
- Fluent in English (Swedish is a plus)