Role Overview
">
This role involves supporting the introduction of new medical devices to commercial phase, managing quality aspects within a specific area, and ensuring operational business compliance with regulatory requirements and cGMP.
">
Key Responsibilities
">
">
* Manage third-party relationships with device component and primary packaging material suppliers.
">
* Evaluate and implement changes related to assigned materials.
">
* Oversight incoming testing activities, ensuring compliance with cGxP, including data integrity and eCompliance.
">
* Review and approve production, QC, and AS&T records.
">
* Support exception investigations.
">
* Review and approval of DHF and DMR documents for Commercial medical devices and combination products.
">
* Report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
">
* Support OpEx improvement projects.
">
* Distribute marketing samples (where applicable).
">
">
Essential Requirements
">
To be successful in this role, you will need:
">
">
* A university degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
">
* At least 3 years or more experience in MS&T, QC, QA or medical device industry.
">
* Experience in relevant operations or third-party management.
">
* Preferably experience in negotiations and global collaboration.
">
* Fluent knowledge of English language (written and spoken), German is an advantage.
">
* Flexibility to work in a fast-paced, quickly changing work environment.
">
* Ability to operate in a global matrix environment.
">
">
Benefits
">
We offer a competitive base salary, attractive incentive program, modern company pension scheme, childcare facilities, learning and development opportunities, and worldwide career possibilities within the group. In accordance with Austrian law, the minimum salary is € 64.023,54/year on a full-time basis.
">
Commitment to Diversity & Inclusion
">
We are committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.
">
Adjustments for Applicants with Disabilities
">
If you require adjustments during the recruitment process due to a medical condition, physical disability, or neurodiverse condition, please reach out to us.