Mira is a San Francisco-based hormonal health companyproviding integrative care and hormonal testing for over 200,000customers. In 2023, we were recognized by Inc. 5000 as America'sfastest-growing femtech company. We started our company to helpwomen and individuals reach their parenthood dreams and make theirfertility journey smoother. Mira’s most important breakthrough wasinventing the market's only FDA-compliant at-home fertility monitorwith quantitative technology. Since the beginning, they have beenon a mission to develop data-driven hormonal health solutions tohelp women make confident health decisions during every stage oftheir lives—from the menstrual stage to menopause. Mira offerssolutions to test, boost, and navigate fertility—starting fromcomprehensive hormone testing and supplements to fertility coachingand online courses. We are committed to helping our customersachieve the highest possible success rates and outcomes; that iswhy our focus is on personalized care, the use of the mostcutting-edge technology, and science-backed data. About theposition We are seeking a Technical Product Manager to drive thedevelopment of cutting-edge in vitro diagnostic (IVD) products fromconcept to commercialization in our fast-paced, mission-drivenstartup. This role blends scientific expertise, regulatory savvy,and strategic leadership to shape the future of women’s hormonalhealth. You’ll lead a technical team, oversee FDA-compliant productdevelopment, and collaborate with cross-functional andinternational stakeholders to bring innovative solutions to life.If you’re ready to challenge yourself at a high-growth femtechleader and make a tangible impact on women’s wellness, join us! KeyResponsibilities: - Regulatory Compliance & Documentation:Revise and prepare FDA documentation, ensuring technical compliancewith applicable regulations and standards. Contribute to thedevelopment of dossiers for regulatory submissions. - ProductStrategy & Collaboration: Partner with the Product team todefine and refine product strategies that align with customer needsand company objectives. Collaborate with internal stakeholders toshape the technical roadmap. - Design Control Leadership: Lead thedesign control process, overseeing the planning, execution, anddocumentation of product development activities to ensure robustand compliant IVD solutions. - Team Building & Management:Build and lead a technical team, working closely with the Directorof Regulatory to establish a lab for product testing andvalidation. Set objectives, organize activities, and providetechnical guidance to team members. - Cross-teams Communication:Act as the primary liaison with QTI to provide updates onCareomedic developments (beyond R&D scope), ensuring seamlessinformation flow across departments. Interface with quality teams,senior leadership, and external partners to facilitate programdiscussions and resolve challenges. - Technical Innovation: Guidethe development and improvement of IVD products by designingexperiments, interpreting data, and presenting actionable insights.Drive technological advancements that enhance the company’sportfolio. - Resource Management: Plan and prioritize resources(human, budget, technical) for technical development and laboratorymaintenance activities, ensuring efficient and effectiveoperations. - Stakeholder Engagement: Communicate complex technicalconcepts effectively through exceptional documentation andpresentations, fostering alignment across organizational levels,including executive sponsors and senior leadership. Requirements -Bachelor’s degree in Biomedical Engineering, Life Sciences, or arelated field (Master’s or PhD preferred). - 5+ years of experiencein the IVD or medical device industry, with a focus on hands-onproduct development and regulatory compliance. - Proven trackrecord in leading technical teams and managing design controlprocesses while remaining actively involved in execution. -Experience with FDA submissions and familiarity with globalregulatory standards. - Strong project management andorganizational skills, with the ability to prioritize and managemultiple initiatives. - Exceptional technical documentation andcommunication skills, with the ability to engage diversestakeholders. - Hands-on expertise in experimental design, dataanalysis, and product testing within a lab environment. -Leadership and team-building capabilities, with experience inmanaging cross-functional and international teams. Details The roleis a remote position, with a 40-hour workweek, flexible workinghours and occasional overlap with the US team. What we offer - Youwill work with a dedicated, highly-engaged, international team ofprofessionals who are passionate about helping couples andindividuals start their families. - We have a fast-paced andcollaborative work environment where we encourage opencommunication, ownership, and independence. - In addition to acompetitive salary, we offer a performance-based bonus system basedon OKR. - We provide professional development opportunities -training courses, workshops, and seminars. Recruiting process Step1: Screening call with HR - Step 2: Assessment task - Step 3:Interview with R&D Director, CTO, Director of RegulatoryAffairs and Quality - Step 4: Final interview with CEO and Head ofProduct. #J-18808-Ljbffr
