QA/RA Manager

Exciting QA/RA Manager opportunity within the Medical Device industry!

They are looking for a Quality and Regulatory Affairs professional with extensive experience in Quality and Regulatory of Medical Device to join their team as a QA/RA Manager!

The key responsibilities of this regulatory role include:

• Executing quality and regulatory processes
• Guaranteeing that regulatory requirements are met in regards to local and national laws and company standards in order to place and/or maintain products on the markets
• Act and/or supervise as Local Safety Officer for local authorities under his/her area of responsibility
• Develop and implement regulatory strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards in country

We’re looking to speak with any candidates that meet the following criteria:

• Fluent German and English
• Minimum of 3-5 years in Regulatory Affairs of Medical Devices
• Experience in all aspects of Regulatory Affairs: Submission Preparation, local regulatory body Device Law/Regulations, Worldwide Regulatory Requirements/Procedures, Project Management, and Negotiations
• Able to work with external entities and in a cross-functional team

This QA/RA Manager opportunity is an initial 6–9-month contract, which is offering an extremely competitive rate for the right candidate. This is a 100% remote-based role, with the offices based in Europe.

If you have read this through and believe you would be a great fit for this Regulatory Operations position, please do not hesitate to apply, or simply reach out to me via email bshepherd@aerotek.co.uk, or just send me a message so we can schedule a call to discuss it further!

If this does not sound like the right role for you but you know someone that could be right for a Regulatory management position, please forward on a method of contact to this person and you could be eligible of a referral fee.