Regulatory Affairs Manager (m/f)

Medical Devices

Stuttgart Area

I am currently working exclusively with a key client located in the Stuttgart area to find an experienced Regulatory Affairs candidate to join their department. The company have an interesting portfolio of non-active products marketed internationally. This role has the possibility to earn further career development within the company, and you would be working in a flat-hierarchy reporting directly to the Director Regulatory Affairs/ Quality Assurance. My client has several manufacturing sites across Europe and has ever growing strength in the German market.

The Role:

• The first duty would be to perform a GAP analysis for the new MDR, which would ideally be completed by the end of Summer
• You would be responsible for clinical evaluations
• The contact point to the relevant agencies, and give exposure to the CE commission
• Regulatory Agreements
• Providing sound Regulatory expertise and guidance to the current Regulatory team members
• Liaison point between the Regulatory Affairs and other departments
• Occasional travel between manufacturing sites within Germany

Your Profile:

• Completed studies in a relative Life Science field, or any other comparable education
• Ideally 3+ years experience working in Regulatory Affairs for Medical Devices of any class
• Sound Knowledge of new MDR, Risk Analysis, Clinical Evaluation and how to conduct a GAP analysis
• Fluency in both English and German is compulsory (C1+)
• Strong communication skills are essential in order to transfer information and insights between sites and internal departments

My client is searching for someone to start as soon as possible, and with this in mind - this position won't be open for very long. In order to be one of the first presented, and therefore with the strongest chance of success - either respond to this advert, or send your application along with your CV directly to d.perkins@sciproglobal.de

Good Luck!