Job Title

Billennium is a global technology company with over 22 years of experience, committed to innovation and empowering businesses. As an employer, we offer a supportive, growth-focused environment where collaboration and creativity thrive. Join us to shape the future of technology together!Job Description:We are seeking a highly skilled and experienced Senior Business Analyst (Remote) to join our team, with a strong background in the medical device industry. The ideal candidate will possess excellent communication skills, a sharp analytical mindset, and the ability to work collaboratively with cross-functional teams including regulatory, R&D, quality, and IT. This role is critical to driving business requirements, process improvements, and system enhancements that align with regulatory standards and business goals.Key Responsibilities:Gather, document, and analyze business requirements for projects related to product development, compliance, and operational efficiency.Collaborate with stakeholders to translate complex business needs into clear functional specifications.Facilitate workshops, interviews, and meetings with cross-functional teams to ensure alignment on goals and deliverables.Work closely with technical teams to support system implementations and process automation initiatives.Ensure solutions align with FDA and global medical device regulatory standards.Support UAT planning and execution, issue resolution, and process documentation.Present findings and recommendations to senior leadership in a clear and concise manner.Qualifications:7+ years of experience as a Business Analyst, with at least 3 years in the medical device or healthcare industry.Strong understanding of regulatory requirements (e.g., FDA, ISO 13485, GxP).Exceptional verbal and written communication skills; able to bridge the gap between technical and non-technical stakeholders.Proficient in business analysis tools such as JIRA, Confluence, Visio, and MS Office Suite.Experience working in Agile/Scrum or hybrid project environments.Bachelors degree in Business, Information Systems, Life Sciences, or a related field.Preferred:CBAP, PMI-PBA, or similar certificationExperience with ERP or PLM systems in the medical device spaceRecruitment process:HR callTechnical InterviewInterview with the dedicated ClientFinal decision/ FeedbackSounds interesting? Click 'Apply' and have a chance to hear more!