Job Description
Senior Regulatory Affairs Specialist sought for a Medical Device Multinational to develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction. The role requires managing technical documentation, global regulatory impact assessments, and regulatory procedures, as well as providing regulatory support for R&D projects, input and approval for new product introductions. Key responsibilities include managing technical documentation, global regulatory impact assessments, and regulatory procedures, as well as providing regulatory support for R&D projects, input and approval for new product introductions. The ideal candidate will have an engineering or science qualification, with 5 years of working experience within R&D/QA/RA in a medical device environment, and excellent technical writing experience within a medical device environment. The candidate should also have attention to detail and accuracy, fluency in English, both written and oral, and ability to work well under deadlines and pressure. Additionally, the candidate should have problem-solving skills for developing creative solutions and meeting objectives, and skills that enable coordination of data, including MS-Office skills. The role is part of a team that interacts and negotiates with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks. The candidate will work closely with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues, and will also support Regulatory inspections at the site as directed. The ideal candidate will be able to prioritize tasks and manage several projects and tasks simultaneously, and interface with all levels of management. The company seeks a highly skilled and experienced Regulatory Affairs Specialist to join their team and contribute to the development and approval of medical devices.