Combination Product Lead

<p><b>Scope and responsibilities: </b></p><ul><li><p><span>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.</span></p></li><li><p>Drive key deliverables within Alvotech’s design control process and author critical documentation to support design verification, design validation, and risk management activities.</p></li><li><p>Collaborate closely with cross-functional specialists—both within and outside the department—to ensure timely completion of design control milestones aligned with program strategy.</p></li><li><p><span>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).</span></p></li><li><p>Develop and maintain strong technical expertise in injection device function, assembly, and testing, as well as regulatory expectations for combination products.</p></li><li><p>Contribute to global regulatory submissions by authoring relevant dossier sections in partnership with technical writers and regulatory teams.</p></li><li><p>Support process improvements, including drafting or revising SOPs and contributing to departmental best practices.</p></li><li><p>Work with QA to ensure accurate, consistent, and audit‑ready DHF documentation.</p></li><li><p>Oversee day-to-day coordination of document reviews, updates, approvals, and collaboration with external vendors; review all incoming technical documents.</p></li><li><p>Conduct design impact assessments for proposed product or process changes.</p></li></ul><p></p><p><b>Job requirements:</b></p><ul><li><p>Bachelor or Master&#39;s degree in a relevant scientific or engineering field</p></li><li><p>Minimum of 5 years of experience in medical devices, combination products, pharmaceutical development, or a related technical field.</p></li><li><p>Strong understanding of design control frameworks, including DHF management, design verification/validation, risk management, and usability engineering.</p></li><li><p>Working knowledge of medical device regulations, particularly MDR 2017/745, and familiarity with expectations for combination products.</p></li><li><p>Solid analytical skills with the ability to make decisions that may influence project timelines and financial outcomes.</p></li><li><p>Proven experience leading complex, cross-functional projects with minimal supervision.</p></li><li><p>Ability to manage tasks of varying complexity and contribute to large-scale development programs.</p></li></ul><p></p><div><div><div></div><div></div><div><p><span><b>What we offer:</b></span></p><ul><li><p><span><b>Meaningful Work:</b> Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people’s lives.</span></p></li><li><p><span><b>Global Growth:</b> Join a fast-growing, international company with a diverse and inclusive culture.</span></p></li><li><p><span><b>Collaborative Environment: </b>Work in a positive, flexible, and innovative setting that values teamwork and creativity.</span></p></li><li><p><span><b>Career Development:</b> Benefit from support for personal growth, internal mobility, and ongoing training opportunities.</span></p></li><li><p><span><b>Cultural Exchange: </b>Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays.</span></p></li><li><p><span><b>Well-being &amp; Perks:</b> Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee.</span></p></li><li><p><span><b>Community &amp; Celebration:</b> Participate in regular social events and celebrate team milestones together.</span></p></li></ul><p></p></div></div></div><div></div>