You will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
You will participate on cross-functional teams, develops global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews testing protocols and reports, labeling and marketing materials, and evaluates proposed device changes. You will be responsible to prepare complex submission to gain approvals for clinical studies and commercial distribution in the United States, Europe, and Canada. WHAT YOU WILL DO: As the Staff Regulatory Affairs Specialist, you will support Stryker's Neurovascular Intracranial Atherosclerotic Disease (ICAD) franchise new products development. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
The agency noted that plastic component fractures in the device might be attributed to multiple issues, including the component’s thickness, the degradation of the material, surgical factors, and patient factors, such as younger patients with higher activity levels. The FDA issued a safety advisory on Stryker Corporation’s (NYSE: SYK) Scandinavian Total Ankle Replacement devices, also known as STAR Ankle, citing the risk of a plastic component breaking after surgical implantation.Īccording to the FDA, the plastic component may break as soon as three to four years after the device is inserted, leading to surgery to repair or replace the device.