Product Development Manager - Drug/Device Combination Products

Product Development Manager - Drug/Device Combination Products

Octapharma

Vienna, Austria

Your new challenges which will inspire you:

• Lead the Design Control process for drug/device combination products and create phase-based Design Control documents (DDP, URS, DRS, DV&V, DTx, DHF, etc.);
• Facilitate the Human Factors/Usability Engineering process and define internal quality assurance requirements as well as SOPs;
• Determine the development strategy and actively support project planning regarding Design Control, Human Factors/Usability Engineering and risk management activities;
• Coordinate the activities of the Human Factor throughout the feasibility, clinical development, registration, and post-marketing phases;
• Interact with internal experts from R&D, Clinical, Medical, Marketing, Quality, and Regulatory and with external suppliers;
• Support with regulatory submissions and various risk management activities;
• Participate with complaint handling as well as with competitive analysis and market research.

Your profile that will convince us:

• University degree in Engineering, Life Sciences, Pharmacy, or other relevant area;
• Minimum 4 years’ experience in combination product development;
• Deep knowledge of regulatory requirements and guidelines (EU and FDA) requirements of medical device and combination products (e.g. IEC 62366, ISO 14971, FDA QSR 21 CFR Part 4, EU MDR 2017/745);
• Experience in project management is a plus;
• Ability to resolve complex problems independently by sharp analytical and strategic thinking;
• Fluency in English (oral/written), and proficiency in German is desirable.

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