Combination Product Lead

Overview of role

Alvotech is seeking a passionate and skilled Combination Product Lead to join our innovative Combination Products and Devices (CPD) team. The CDP team designs and develops drug delivery solutions that are reliable, accessible, and in keeping with patient needs. The Combination Product Lead works with Human Factors, Risk, Technical, and program strategy specialists to ensure the successful development, verification and validation of our products and maintenance of our combination drug product files (DHFs and DMRs).

We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.

We encourage you to visit our Career page (link: Join us - Alvotech - Better Access Better Lives) It offers valuable insights into our culture, values, and the innovative work we do.

Key Responsibilities:

• Lead the compilation of DHFs, including usability files, design verification testing, and risk assessments.
• Draft key deliverables of the design control process.
• Collaborate with specialists to deliver design verification, validation, and risk documentation.
• Coordinate with regulatory bodies to compile technical files for submission, ensuring compliance with MDR 2017/745 and EU Medical Devices Directive 93/42/EC.
• Maintain technical knowledge in the function, assembly, and testing of injection devices.
• Stay updated on regulations related to combination drug products.
• Author sections of global submission dossiers.
• Contribute to process improvements and SOP drafting.
• Maintain DHF documentation with QA.
• Coordinate document review, updates, and approval for technical projects.
• Perform design impact assessments for proposed design changes.
• Schedule and manage stage reviews.

Qualifications:

• Master’s Degree with a minimum of 7 years of relevant work experience.
• Proven experience in life cycle management of combination products.
• Strong knowledge of design control processes and regulatory requirements (ISO-13485, ISO-14971, MDR, 21 CFR part 4, ISO-11608, IEC-62366, ASTM 1980, ISO 23908 etc.)
• Proficiency in risk management and design verification/validation (ISO-13485, ISO-14971)
• Experience with technical documentation and regulatory submissions.
• Excellent verbal and written English communication skills.
• Ability to work independently and as part of a team.
• Self-motivated, adaptable, and positive attitude.