Combination Product Lead

responsibilities:** - Lead the compilation of Device History Files for Alvotech’s combination drug product(s) from start to finish including human factors (usability) file, design verification testing, and risk assessments, through design transfer. - Drive key deliverables within Alvotech’s design control process and author critical documentation to support design verification, design validation, and risk management activities. - Collaborate closely with cross-functional specialists—both within and outside the department—to ensure timely completion of design control milestones aligned with program strategy. - Works closely with notified body to compile the device technical files for notified body submission in keeping with Medical Device Regulation (MDR) 2017/745 (EU Medical Devices Directive 93/42/EC, as amended). - Develop and maintain strong technical expertise in injection device function, assembly, and testing, as well as regulatory expectations for combination products. - Contribute to global regulatory submissions by authoring relevant dossier sections in partnership with technical writers and regulatory teams. - Support process improvements, including drafting or revising SOPs and templates and contributing to departmental best practices. - Work with QA to ensure accurate, consistent, and audit‑ready DHF documentation. - Oversee day-to-day coordination of document reviews, updates, approvals, and collaboration with external vendors; review all incoming technical documents. - Conduct design impact assessments for proposed product or process changes. - Present design control milestones and project insights to cross functional team during formal stage reviews. ## **Job requirements:** - Bachelor or Master's degree in a relevant scientific or engineering field. - Minimum of 5 years of experience in medical devices, combination products, pharmaceutical development, or a related technical field. - Strong understanding of design control frameworks, including DHF management, design verification/validation, risk management, and usability engineering. - Working knowledge of medical device regulations, particularly MDR 2017/745, and familiarity with expectations for combination products. - Solid analytical skills with the ability to make decisions that may influence project timelines and financial outcomes. - Proven experience leading complex, cross-functional projects with minimal supervision. - Ability to manage tasks of varying complexity and contribute to large-scale development programs. ## **What we offer:** - **Meaningful Work:** Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people’s lives. - **Global Growth:** Join a fast-growing, international company with a diverse and inclusive culture. - **Collaborative Environment:** Work in a positive, flexible, and innovative setting that values teamwork and creativity. - **Career Development:** Benefit from support for personal growth, internal mobility, and ongoing training opportunities. - **Cultural Exchange:** Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays. - **Well-being & Perks:** Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee. - **Community & Celebration:** Participate in regular social events and celebrate team milestones together. ### About Us At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars. We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business. Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale. If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide. If you have any technical issues, please contact: hr@alvotech.com Read More © 2026 Workday, Inc. All rights reserved.