לוח משרות דרושים רפואה ופארמה עבודה היברידית

we are looking for a Senior Medical Manager.
Responsibilities:
Lead a medical team responsible for the design, development, and deployment of features and product lines within (in partnership with the Product and Engineering teams). Specifically related to flagship Risk Adjustment Solution.
Regular data analysis and clear presentation of conclusions to direct business and product decisions
Medical validation of product and features
Closely work with developers data scientists, and data analysts to bring medical and medical-product expertise to all aspects of R&D
Support marketing and sales teams in the development of marketing materials, delivering webinars, attending conferences and sales demos
Manage a team of analysts (medical students) to support your efforts in the above

Lead and manage clinical regulatory submissions, including IDE submissions, IRB/EC applications, amendments, and ongoing study maintenance.
Serve as the regulatory lead for US and EU clinical investigation activities, supporting first?in?human, feasibility, and pivotal studies.
Prepare, review, and maintain clinical regulatory documentation, including protocols, Investigators Brochures, clinical risk sections, and regulatory responses.
Support regulatory strategy development for clinical programs, ensuring alignment with development, clinical, and business objectives.
Act as a primary regulatory interface with FDA and European regulatory bodies related to clinical studies.
Collaborate closely with Clinical, R D, Quality, Biostatistics, Operations, and external clinical partners/CROs.
Participate in cross?functional discussions supporting new product development and clinical evidence

we are looking for a Senior Regulatory Affairs Specialist Medical device.
The Senior RA specialistwill be responsible for leading global market expansion and new product introductions for Class I, Class II (US) and Class IIa (EU) medical devices. Responsibilities include planning and executing regulatory submissions for the US, EU, and other international markets, creating and maintaining technical files, managing complaints, overseeing change activities, and ensuring post market compliance. The role collaborates with cross functional teams - including QA, R&D, Clinical, Manufacturing, Operations, Marketing, and Commercial - to ensure compliant efficient, and timely market access throughout the product lifecycle, including sustained compliance.
Responsibilities:
Market Expansion & Global Regulatory Registrations:
Prepare and maintain global regulatory submissions (e.g., India, Australia, Singapore, Mexico) and author full submission packages. (e.g., EU MDR Annex II/III TD, US 510(k), ANVISA, SFDA, NMPA).
Monitor regulatory changes and ensure sustained compliance across all markets, including labeling, UDI, and post-market updates.
Conduct jurisdiction -specific impact assessment for product changes and manage global propagation of design, labeling and UDI updates.
Collaborate with R&D, Operations, Marketing, and product teams throughout new product development and commercialization to ensure regulatory alignment
Review technical documentation and ensure compliance across the full product lifecycle
Serve as the QA/RA point of contact for cross-functional programs and regulatory-related initiatives.
Maintain existing registrations, manage renewals and variations, and oversee global portfolio compliance.
Develop and execute global regulatory strategies for new market entry (US 510(k), EU MDR, Canada MDL, LATAM, APAC, MEA), including interpret country-specific requirements, identification of testing and labeling needs, and creation of submission roadmaps.
Lead pre-submission meetings and manage interactions with health authorities and notified bodies.
Ensure compliance with ISO 13485, 21 CFR 820, EU MDR, and applicable country regulations.