Occlutech is the leader in developing innovative products for the treatment of structural heart diseases. The Company develops and markets occlusion-based technology to repair congenital heart defects and para-valvular leaks in over 80 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at www.occlutech.com.
We are now looking for an Registration and Administration Specialist to strengthen our growing registration department.
Position description: Primary responsibilities will include assisting the Company’s Global Head of Regulatory Affairs and Quality Management in filing and maintaining international medical device registrations. The position requires interacting with regulatory and clinical affairs, as well as other professionals at Occlutech’s sites (Sweden, Turkey and Germany) and with the Company’s OEM manufacturers, suppliers and distributors worldwide.
Submitting, filing, monitoring and maintaining international product registrations
Compiling, legalizing and shipping of regulatory and other required legal documents
Coordination of additional testing procedures as may be required; including coordination for test material shipping
Interacting with third party manufactures, distributors or agents as may be required (e.g. supporting international tenders)
Maintaining international product registration data base (timelines, status & costs)
Provide timely & regular updates to the Global Head of RA/QM and Senior Management
Compiling of data, summaries and reports
Status of ongoing registrations
Changes of timelines, rules and regulations
Any new issues that may arise
General administrative tasks such as copying, filing, etc.
Solid experience of administration and know-how in regards to finding information about current laws and regulations in different countries. Experience of Regulatory Affairs is an advantage.
Ability to work well unsupervised and in a team environment
Independency, detail orientation as well as creativity
Capability to manage multiple projects at the same time
Ability to work in a diverse, multinational environment
Excellent written and verbal communication skills both in Swedish and English. Additional language skills are an advantage
Are you interested?
Jobbsafari serves as the recruitment partner for this position. If you have any questions regarding the position, you are welcome to contact recruitment consultant at Jobbsafari Jonathan Allirol at +46 73 59 59 895 or firstname.lastname@example.org.
Please send your CV and application in English and apply for the position by clicking at the link below no later than 7th of May 2018. Interviews will be conducted on a rolling basis, so please do not wait with sending your application.