Responsibilities

The Senior Regulatory Affairs Specialist will ensure all activities comply with applicable laws, including the Foreign Corrupt Practices Act (FCPA) and Stryker’s Code of Conduct, prioritizing and managing regulatory submissions for new products across all risk classes. They will prepare and submit documentation to health authorities, respond to deficiency letters, and participate in meetings or discussions to support approvals, while also reviewing and assessing change notifications and collaborating with international RA teams. Furthermore, the role involves supporting audits and quality support, identifying regulatory procedure gaps, developing SOPs, and promoting continuous improvement within the RA and QA functions, as well as providing KPI data and supporting training materials.