Medical Device Expert

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.
- 2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact This is one such role
- Are you ready to make a difference?**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

**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**:

- 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

**You’ll receive**:
Competitive salary; Performance based annual bonus; Work/life integration; Eligible to Sandoz pension plan; 30 working days' holiday per calendar year; Subsidized on-site cafeteria; Additional benefits.**Why Sandoz?**
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 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**

**Commitment to Diversity & Inclusion**:
Sandoz, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
- Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.-
**Division**
- Novartis Technical Operations

**Business Unit**
- QUALITY

**Country**
- Germany

**Work Location**
- Rudolstadt

**Company/Legal Entity**
- Aeropharm GmbH

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No