What are the responsibilities and job description for the Biological Safety Lead position at Swoon?
Job Title: Biological Safety Lead
Contract Duration - 1 Year/W2
Job Overview
We are seeking an experienced Neuro Research Scientist / Biological Safety Lead to lead biological safety and preclinical research activities supporting innovative neuro-based medical devices. This role will serve as the scientific expert for biological safety, partnering with R&D, Regulatory Affairs, Clinical, Quality, and Manufacturing teams throughout the product development lifecycle.
Key Responsibilities
- Lead biological safety evaluations in accordance with ISO 10993.
- Develop biological evaluation strategies, biocompatibility assessments, and risk assessments for medical devices.
- Design and oversee preclinical research, including in vivo studies and tissue histology evaluations.
- Support neuro-based product development, including stereotactic technologies, neurosurgery, neuro-oncology, and neuro-endoscopy applications.
- Prepare and review study protocols, scientific reports, and regulatory documentation.
- Present scientific findings to internal stakeholders, regulatory agencies, and external collaborators.
- Serve as the biological safety subject matter expert across multiple product development programs.
Required Qualifications
- Master's degree in Neuroscience, Biology, Toxicology, Biomedical Science, Materials Science, or a related scientific discipline (PhD or DVM preferred).
- 5 years of medical device R&D experience.
- Extensive experience with ISO 10993 biological safety evaluations and biocompatibility assessments.
- Hands-on experience with preclinical in vivo research, large animal models, and tissue histology.
- Experience supporting FDA or other global regulatory submissions.
- Excellent scientific communication, technical writing, and cross-functional collaboration skills.
Preferred Experience
- Neuro-oncology, neurosurgery, neuro-endoscopy, or stereotactic medical devices.
- Regulated medical device development.
- Biological safety risk assessments and scientific leadership within cross-functional product development teams.
If you have a strong background in biological safety, medical device R&D, and neuroscience, we'd love to hear from you!
Salary : $85 - $91