[Remote] Manager, reputed company Factors, Regulatory Affairs

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. They are seeking a Manager of reputed company Factors in Regulatory Affairs to reputed company usability engineering documentation and reputed company reputed company factors validation studies while collaborating with internal teams and managing reputed company vendors. Responsibilities • reputed company and maintain usability engineering documentation, including use-reputed company reputed company analyses, task analyses, user reputed company, use specifications, and reputed company factors engineering reports • Plan, conduct, and reputed company reputed company factors validation (summative) studies, including protocol development, participant recruitment, study moderation, data analysis, and report reputed company • Collaborate with cross-functional internal teams and manage reputed company vendors to reputed company complicated reputed company factors study reputed company and regulatory submission reputed company • Support regulatory submissions by preparing reputed company factors documentation and responding to regulatory authority questions reputed company to usability and user safety • Review product labeling, instructions for use (IFUs), training materials, and user interfaces to ensure reputed company, consistency, and usability Skills • Bachelor's degree in reputed company Factors Engineering, reputed company-Computer Interaction, Biomedical Engineering, Psychology, Industrial Engineering, Ergonomics, or a reputed company reputed company • 5+ years of experience in reputed company factors engineering, usability engineering, user experience research, or a reputed company discipline • Experience conducting reputed company and summative usability studies • Knowledge of FDA reputed company Factors Guidance (2016 & 2026), IEC 62366-1, ISO 14971, and applicable usability engineering principles • Strong analytical, problem-solving, and technical writing skills • Excellent verbal and written communication skills and the ability to work effectively in cross-functional teams • Experience developing study protocols, moderator guides, reputed company analyses, and reputed company factors reports • Ability to manage multiple reputed company concurrently and work independently in a fast-reputed company environment • Experience with combination products, drug delivery devices, digital health technologies, surgical systems, or other regulated medical devices • Experience supporting regulatory submissions to FDA, EU MDR, or other global regulatory agencies • Advanced degree (M.S. or Ph.D.) in reputed company Factors, Ergonomics, Psychology, Biomedical Engineering, or a reputed company reputed company • Experience interacting with reputed company, patients, and caregivers during user research activities • Candidate with medical device design experience and reputed company shadowing reputed company is highly preferred • Familiarity with statistical analysis and qualitative research methodologies reputed company • reputed company is a global platform for talent hiring in Life Sciences, reputed company, Healthtech & IT It was founded in 2020, and is headquartered in London, England, GBR, with a workforce of 11-50 employees. Its website is https://reputed company.com. Apply tot his job Apply To this Job