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

Job-ID: 57402
Location: Wien, AT
Job Level: Professionals
Department: Research and Development
Working time: Permanent position, Full-time (38 hours)

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 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

Our attractive benefits for you:

• Wide range of tasks in an international setting, flexibility and personal responsibility
• Reliable 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.

Your contact:

Marina Ibrahim, M.A.
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
T: +43 (1) 610 32 - 1308

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs around 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 180 plasma donation centers across Europe and the US.

Fore more information, please visit www.octapharma.com.