Overview of the Job Role
Alvotech is looking to hire a Combination Products Lead (CP Lead) to join the Combination Products & Devices department (CPD) in Stockholm, Sweden. This is an exciting opportunity for an experienced professional with a background in combination products, medical devices, or pharmaceutical development to play a key role in advancing Alvotech's product portfolio.
In this role, you will lead design control activities and Device History File (DHF) development across product programs, working closely with cross-functional teams, external partners, and regulatory stakeholders. You will drive critical development activities, ensure compliance with applicable regulations and standards, and contribute to the successful delivery of innovative combination products. As Alvotech continues to grow, this position offers a unique opportunity to combine technical leadership with strategic impact in a collaborative and fast-paced environment.
Scope and 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.