Senior Biomedical Research Scientist
4 weeks ago
HOYA Surgical Optics is a leading provider of innovative ophthalmic devices and solutions that empower cataract surgeons worldwide to achieve better surgical outcomes and practice results.
We are dedicated to improving the vision and quality of life for millions of people suffering from cataracts, and helping them celebrate life visually.
Our CommitmentWe are committed to delivering high-quality products and services that meet the evolving needs of our customers and regulatory requirements.
Our team is passionate about innovation, collaboration, and excellence, and we strive to create a conducive work environment that fosters growth and development.
The RoleWe are seeking a highly skilled and experienced Senior Biomedical Research Scientist to join our team.
The successful candidate will be responsible for ensuring the biocompatibility of our intraocular lenses and related ophthalmic devices, and will work closely with cross-functional teams to achieve business and operational objectives.
Key Responsibilities- Lead activities related to biocompatibility assessment to ensure compliance with ISO 10993 series, ISO, and ISO standards
- Initiate and conduct shelf life studies to determine the stability and safety of medical devices over time
- Manage change requests related to manufacturing processes, design modifications, packaging, sterilization, and other critical aspects of device production
- Comply with MDR guidelines for EU submissions, which includes preparing and reviewing technical documentation
- Write and review detailed technical reports related to biocompatibility, ensuring accuracy and compliance with regulatory standards and internal quality systems
- Conduct gap assessments to identify discrepancies between current practices and updated standards, and develop mitigation strategies to ensure compliance
- Stay up-to-date with FDA regulations and biocompatibility-related regulations in China, Japan, and other Asian markets to ensure all products meet global regulatory requirements
- At least 5 years' experience of biomedical research in biomedical research, with a focus in ISO10993, ISO, and standards and testing
- Experience with Class 2B/3 medical devices, specifically intraocular lenses
- Supported regulatory submissions, prepared and updated biocompatibility-related documents
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Our team is passionate about innovation, collaboration, and excellence, and we strive to create a conducive work environment that fosters growth and development.
Join our team and contribute to the development of innovative ophthalmic devices and solutions that improve the lives of millions of people worldwide.
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