Senior Regulatory Affairs Specialist - Berlin (F/M)

Medical Devices

One of my key clients based in the Berlin area are searching for an experienced Regulatory Affairs professional to take the next step in their career. The company have a strong Global presence within the Medical Device industry and are looking for a highly motivated candidate with enough Regulatory know-how to contribute high levels of expertise to the Regulatory department.

Your Tasks:

• Provide Regulatory Direction to development of project teams as a core team member
• Create Regulatory Strategy for new products
• Regulatory Submissions
• Submissions of Regulatory Documentation for market approval as well as providing routine regulatory information to associates and affiliates
• Risk Management duties
• Reviewing of labelling and compliance
• Ability to conduct training and guidance to more junior colleagues
• Liaison with regulatory and governmental agencies
• Among many others

Your Profile:

• 4+ Years experience in regulatory affairs for Medical Devices
• Experience working with Implants is considered a bonus
• Technical/ Engineering degree or a comparable Life Science Field is required
• Familiar with EU Regulations and FDA
• Global regulation knowledge is considered a bonus
• Strong communication skills, as well as a motivated attitude which shows a high level of responsibility and leadership qualities.

This is a brief outline of the position, for more information please either respond to this advert or directly send your application to d.perkins@sciproglobal.de