Senior Regulatory Affairs Specialist wanted to lead regulatory strategy and compliance for complex projects. A skilled technical writer is required to develop and implement plans, coordinate data, and manage global regulatory impact assessments. Key responsibilities include managing updates to global regulatory procedures, providing regulatory support for R&D projects, applying technical solutions to problem solving and quality improvement projects, and maintaining regulatory procedures to ensure continued compliance. In addition, the successful candidate will work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues, support regulatory inspections at the site, liaise with other departments to ensure correct supporting data generated and provided in a timely manner, and interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks. To be successful, the ideal candidate will have an engineering/science qualification, 5 years of working within R&D/QA/RA in a medical device environment, and excellent technical writing experience within a medical device environment.