Device/Combination Product Manager

Role: Lead technical development and regulatory compliance for medical device and drug-device combination products within Viking's pipeline, primarily focusing on injectable delivery systems for obesity and metabolic indications. Responsibilities: establish and oversee design controls, risk management, human factors, and verification/validation for devices such as prefilled syringes and autoinjectors; manage external device partners; contribute to regulatory submissions (INDs, CTAs, NDAs/BLAs); define device specifications and testing; and support cross-functional teams to ensure phase-appropriate, on-time delivery. Requirements: B.S. or M.S. in Biomedical or Mechanical Engineering or related field with 8+ to 10+ years of industry experience in developing combination products; deep knowledge of applicable regulations (21 CFR Part 4, ISO 13485, ISO 14971, IEC 62366-1); experience managing external suppliers and regulatory documentation; familiarity with injectable parenteral systems, preferably with peptide or GLP-1/GIP products. Preferred: experience with cold-chain considerations and early-stage development for metabolic therapies. HighValue: combination products, regulatory submissions, device risk management, human factors engineering, injectable delivery systems, biotech/pharma. WorkSetup: Not specified.