Medical Device specialist - Project Contractor

About the position
Our customer in Helsingborg is offering a contractor position for someone that can provide leadership and ensure compliance with European in a global project which aims to develop a new medical device product with a software. Support and drive the end-to-end product development from a quality & compliance perspective to enable successful product registration in EMEA and to fulfill applicable European requirements including crafting and approving relevant documentation.
Collaborate with various other stakeholders locally, regionally and even globally.
Knowledge of EU Medical Device regulations, previous experience with software development as Medical Devices is a merit/beneficial


Responsibilities
• Drive and ensure full R&D Q&C support in project Apricot
• Experience working in product development projects
• Apply medical device expertise in the project
• Manage related communication to all stakeholders
• Manage product development documentation in a fully compliant manner
• Ensure compliance with regional requirements, and internal J&J requ.
• Provide software development support as per project need.
• Collaborate with stakeholders in the project to ensure flawless completion of the project activities, and accurate and timely reply to stakeholder requests.


Your profile
Education Level: Scientist (Pharmacist, Engineer, Biologist, Chemist, etc.)
Ability to build partnerships internally and externally
Mature leadership skills

Language requirement: Excellent in English and one or more of any of the Nordic (Swedish, Finnish, Norwegian, Danish) languages (write, read and speak)
Advanced level in Excel (mandatory & non-negotiable)
Analytical, structured, self-motivated, energetic and self-disciplined person
Problem solver
Fast learner
Good communication skills
Attention to detail and at the same time ability to understand the big picture
Able to work in a high-paced environment

General understanding of the Medical Devices and Pharma industry and MD registration process
Excellent collaboration skills



About the organisation
This is a consultant assignment at a Pharmaceutical Company in Helsingborg for 40-60% during nine months. During this time you will be hired by QRIOS.

QRIOS Life Science & Engineering can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles. Read more about how it is to be a consultant through us: https://www.qrios.se/karriar/tips/konsult/.

It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.