342262BR
24. Juni 2022
Germany

Job Description

600 million - that's how many people worldwide suffer from asthma and COPD. Many of the innovative drugs are expensive. Sandoz is committed to providing affordable generic drugs for respiratory diseases.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Provide technical leadership for assigned international and local Medical Devices & Combination Products across late stages of development through post marketing and product end of life
• Subject Matter Expert for medical device processes following process product/process transfer
• Responsible for compliance of the Design-Dossier incl. change control and support of regulatory filings for the assigned Medical Devices & Combination Products, technical support for complaints
• Assure compliance with applicable GMP, regulatory, ISO 13485, 21CFR820 and other professional requirements for Combination Products throughout life cycle
• Support post market activities like post market surveillance, vigilance, annual review etc.
• Address complex technical issues and set up projects accordingly
• Design and control optimization projects relevant to the specific expertise
• Provide the necessary support in any internal or external audit in addition to providing input to, and review regulatory documentation
• Provide technical expertise ensuring quality and compliance for Medical Devices and Combination Products

Diversity & Inclusion / EEO

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:
• Bachelor of Science, Master’s, or Ph.D. degree in the fields of Mechanical Engineering, Chemical Engineering, or a similar scientific degree
• Minimum 2 years of experience in GMP manufacturing relevant to the specialist area of expertise, e.g., Medical Device Company and/or QA/QC, hands-on experience in Combination Products
• Thorough understanding of product processes, GMP, ISO 13485, 21CFR820 and Part 4
• Design Control /Life cycle management for European and US-FDA requirements
• Fluent in English

Desirable Requirements:
• German language
• Strong communication skills

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

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 Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
SANDOZ
NTO QUALITY
Germany
Rudolstadt
Information Technology
Full Time
Regular
No
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342262BR

Medical Device Expert (d/f/m)

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