Combination Product Lead

alvotech.is

Not specified
Device history file compilation
Design control process
Medical device regulation (mdr)
Alvotech is seeking a Combination Product Lead to oversee the development and documentation of Device History Files for their combination drug products, ensuring compliance with medical device regulations. The ideal candidate should have a strong background in medical device development, regulatory submissions, and project management, with at least five years of relevant experience

Job Summary

  • Lead the compilation of Device History Files for Alvotech’s combination drug product(s) from start to finish.
  • Collaborate closely with cross-functional specialists to ensure timely completion of design control milestones aligned with program strategy.
  • Benefit from support for personal growth, internal mobility, and ongoing training opportunities.

Matching Summary

Match Score: 85

Alvotech is seeking a Combination Product Lead to oversee the development and documentation of Device History Files for their combination drug products, ensuring compliance with medical device regulations. The ideal candidate should have a strong background in medical device development, regulatory submissions, and project management, with at least five years of relevant experience.

Skills & Requirements

Must-have

  • Device History File compilation
  • Design control process
  • Medical Device Regulation (MDR)
  • Injection device expertise
  • Global regulatory submissions

Nice-to-have

  • Process improvement contributions
  • Collaboration with external vendors
  • Positive and flexible environment
  • Teamwork and creativity

Key Requirements

  • Minimum of 5 years of experience
  • Bachelor or Master's degree
  • Strong understanding of design control frameworks
  • Working knowledge of medical device regulations
  • Proven experience leading complex projects

Work Rights

Not specified

Tailored Resume

Cover Letter