Om jobbet
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 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.
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.
