Labeling Specialist 100%
Product labels and labeling are one of the most important forms of documentation that a medical device company can produce as the labeling has a direct impact on the way the customer interacts with the product itself. No product can be sold without correct labeling, and as a Labeling Specialist, you will have a crucial role in ensuring that our product labels fulfill the requirements of Regulation (EU) 2017/746 (IVDR).
Product Labeling team is part of the Operations Support at the Roche Diagnostics International (RDI) and is responsible for the labels of all the RDI products. The team manages the product labeling process, creates and approves the individual labels and closely collaborates with the Manufacturing, R&D, Quality and Regulatory Affairs, also at other Roche Diagnostic Sites. The mandate of the team is, to reliably deliver the product labels, put regulatory requirements into practice and continuously improve what it does.
Part of the tasks of this position is specifically acting as an interface for the Labelling Department in Mannheim, therefore language Skills in German and English Language are very important. In addition, the candidate will support the Consumables Departments in all labelling related issues. We are searching for candidates with a proven background in the below related fields (must have criteria), only background in a Pharmaceutical Production role is not fully sufficient. Please do not upload candidates which have already been rejected on the former posting JP 6835 which has been opened in May this year.
In case there would be a very good candidate, which is only able to start later then mentioned below, the team could consider this.
Tasks & Responsibilities:
- Updating the product labels and related documentation to fulfill the Regulation (EU)
- Participating in cross-functional and cross-business Area project teams
- University degrees in Engineering / Life science / or related fields (as example Natural Sciences, Regulatory Affairs, Quality Management) or corresponding working experience in Regulatory Affairs / Labelling or QA
- Basic knowledge of regulatory and normative guidelines (ideally of new EU Regulation 2017/746)
- Experience in working in a highly regulated environment
- Excellent communication skills in English, good communication skills in German (interaction with Site in Mannheim)
- Ability to see the big picture but also an attention to detail when needed
- Good analytical and problem-solving skills
- Understanding of processes and process improvement
- Good team working skills
Information for you:
- Start date: 04.01.2021
- End date: 31.12.2021
- Extension: Yes
- Remote / Home Office: Yes
- Personal and individual advice and support
- Fair and contemporary remuneration
- Further training opportunities via Temptraining
- Once the contract expires, we support you in finding employment solutions
We look forward to receiving your application in German and English. Please send your CV and all further certificates by e-mail to Ms Saranda Berisha (firstname.lastname@example.org).