Product Development Manager (m/f/d) - Drug/Device Combination Products

Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are now hiring for our team.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 SOPsDetermine the development strategy and actively support project planning regarding Design Control, Human Factors / Usability Engineering and risk management activitiesCoordinate the activities of the Human Factor throughout the feasibility, clinical development, registration, and post-marketing phasesInteract with internal experts from R&D, Clinical, Medical, Marketing, Quality, and Regulatory and with external suppliersSupport 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 areaMinimum 4 years’ experience in combination product developmentDeep 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 plusAbility to resolve complex problems independently by sharp analytical and strategic thinkingFluency in English (oral/ written), and proficiency in German is desirableOur attractive benefits for you:Wide range of tasks in an international setting, flexibility and personal responsibilityReliable employer with generous employee benefits and a salary customary in the market.Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more:Additional information:The minimum gross wage according to the collective agreement (chemical industry) for your new job is EUR 3.909,67. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed.We are looking forward to new, committed employees who join forces with us to promote our strong growth in order to keep enabling our patients to live a better life - because it is in our blood! Is it in your blood too? We are looking forward to receiving your application via our online career portal.Your contact:Marina Ibrahim, M.A.
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
T: +43 (1) 610 32 - 1308