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Device Project Lead

vor 4 Wochen

Kundl, Österreich Novartis Vollzeit

1 is our position in the generics market in Europe and our short term goal for US. A division of Novartis, Sandoz is a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide. Sandoz has a growing pipeline of medical device and drug/device combination projects. To meet our ambitious future portfolio needs, we are seeking a Device Project Lead in the development of medical and drug delivery devices. By successfully leading the development of the medical devices/combination products, you will help to launch commercially competitive products that will increase access for our patients.
The role will be based in Kundl, Austria.
Your key responsibilities:

- in relation to combination products (or device constituent parts thereof) and standalone medical devices:

- Project leadership (planning, co-ordination, specifications, risk management, documentation, design transfer etc.); and
- Development oversight (market research; user research; concept generation, development and analysis; detail design (e.g. including 3D CAD and engineering drawings); ergonomics and usability (including HF/UE documentation); design reviews).
- creation and management of Design History Files and associated documentation for selected combination products in accordance with the annual plan and objectives, and relevant standards and guidances e.g. ISO13485, 21 CFR Part 820.30, 21 CFR 3.2(e). etc;
- lead, represent, and manage cross-functional device project teams;
- management of activities in accordance with project strategies, budget, timelines, regulatory, quality, and professional standards;
- enabling operational excellence in compliance with the current and anticipated professional trends;
- performing activities in compliance with Good Manufacturing Practice; and
- ensuring inspection readiness.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

What you’ll bring to the role:

- knowledge of GMP and international device regulations;
- ability to communicate and collaborate effectively in a highly international and diverse setting;
- track record of goal-driven behavior, problem solving, ability to make pragmatic decisions, readiness for new challenges; and
- fluency in English,

Desired skills:

- work experience in medical devices/combination product development;
- knowledge of regulatory/QA requirements for medical devices/combination products; and
- digital excellence and automation of documentation management.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Sandoz
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. GJFA 5: In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position, the minimum salary is € 54,788.30 /year (on a full time basis). We also offer a potential market-oriented excess payment in line with your experience and qualifications.
Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

**Division**

SANDOZ

**Business Unit**

Sandoz Global Development

**Country**

Austria

**Work Location**

Kundl

**Company/Legal Entity**

Sandoz GmbH

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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