| Position : Business Analyst - Software as a Medical Device (SaMD) at Remote, Remote, USA |
| Email: [email protected] |
| Hello Associate, Hope you are doing well We have the below requirement open. Please send me your genuine candidate on my email ID [email protected] Position : Business Analyst - Software as a Medical Device (SaMD) Location : Remote Duration : Long Term Job Description : Work with project product owner and multifunctional team to gather and define precise requirements for medical devices applications. Convert complex business, medical and regulatory requirements into detailed functional specifications and user stories for development teams. Work with cross-functional teams to guide the development process. Facilitate risk management processes including risk analysis, mitigation strategies, and documentation. Support the validation and verification processes of medical device application development. Maintain up-to-date documentation on project specifications, design changes, and regulatory compliance efforts. Required Skills & Experience: Minimum of 5+ years of experience as a Business Analyst, with at least 2 years focused on SaMD or medical device projects. Excellent requirement management and documentation skills Experienced in working with Global team In-depth knowledge of regulatory standards and quality management systems for medical devices Strong analytical, problem-solving skills, and the ability to manage complex projects in a highly regulated environment. Excellent communication skills with proficiency in negotiating and influencing across multiple levels of an organization. Experience with Agile and traditional project management tools such as JIRA, Confluence, or Trello. Proficiency in using requirements management and diagramming tools like Visio or Lucidchart to map out processes and workflows. -- Keywords: information technology Idaho |
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| Tue Feb 06 00:51:00 UTC 2024 |