Research Assistant in Medical Device Documentation
- My work focuses on the translation of a novel medical implants (intended for anterior cruciate ligament repair) from an academic research setting to the clinic.
- The implant, (BioLig) is intended to be a permanent implantable device, manufactured from biodegradable polymers.
- I will also be supporting two other novel medical device projects (BioYarn and BioPatch), and these three products hold the potential for improved patient outcomes, by providing biophysical cues to the endogenous cell population.
- Roles involve cleanroom manufacture of product to GMP standards, establishing QMS procedures for the products and navigating the relevant regulatory pathways to effectively evidence the pre-clinical safety and performance of the devices.
- I have previous experience in the medical device industry, having previously worked at Zimmer Biomet within regulatory affairs, focusing on product registration.