Regulatory Affairs Assistant

Johnson & Johnson Medical is offering a staffing opportunity with an internal project within our Regulatory Affairs department located in the Stockholm, Sweden.

During this assignment which is set out to be initiated in October and last for at least six months, you will be employed by Manpower

Overall purpose of job

Ensure compliance with local regulatory requirements, the national and international guidelines and the J&J policies under the Direction of local Regulatory Affairs Lead with regards to Johnson & Johnson Medical and the related project.

Collaborate with Manufacturers, Authorized Representatives and Global Teams, regarding Swedish, Finnish, Danish, Norwegian legislation and related requirements.



Essential duties and responsibilities



* Label and Instruction for Use - review and approval, and the management thereof.
* Update of RA database.
* Handle all necessary activities for the release of SKU (codes) restrictions.
* Local Management of the MV Project and related communication to all stakeholders.
* Ensure regulatory compliance of Medical Devices (MD) for their access to the market of Sweden, Finland, Denmark and Norway.
* Identify Regulatory Issues & strategies concerning MD, in the scope of the Project, report them to the relevant RA Leaders (at global and local level), investigate and suggest solutions to resolve them.
* Support for One MD Organizations in Sweden, Finland, Denmark and Norway related to the Project.
* Provide regulatory support to ensure consistent collaboration with franchises and EMEA/ Regulatory Affairs, and act as the main contact person for any matters related to the Project impact issues.
* Collaborate with local Commercial, Marketing, Tendering, Finance & Supply Chain teams, to ensure flawless completion of the Project and related activities, and accurate and timely reply to stakeholder requests.



Special requirements

* Excellent in English and one or more of any of the Nordic languages (Swedish, Finnish, Norwegian, Danish)
* Advanced level in Excel (mandatory & non-negotiable)
* Analytical, self-motivated, energetic and self-disciplined person
* Problem solver
* Fast learner
* Good communication skills
* Attention to detail
* Able to work in a high-paced environment



Previous experience in Medical Devices or Pharma industry will be beneficial.



Contact

You apply for the position via the application link. As the selection will take place on an ongoing basis, it is important that you send in your application as soon as possible. The position may be filled before the last application date. For more information, you are welcome to contact responsible recruitment consultant maria.fant on tel. 08-452 33 77.



Welcome with your application!