Job Details:
* Regulatory Affairs Specialist/Manager * Key position * Diagnostics * Austria * permanent *
Here is a leader in the Diagnostics sector, developing and manufacturing medical devices globally. A position has recently opened up for a Regulatory Affairs Specialist / Manager to join the team - a permanent job with solid career development prospects both locally and internationally, and a key position working with R&D and manufacturing on site. In this versatile role you will be jointly responsible for regulatory compliance and processes for products developed, produced and distributed by the parent company.
Day to day tasks to include
- Preparing and submitting national and international product approvals, as well as maintaining and amending existing approvals. Experience in submissions into China, the DACH area and central Europe, also the USA will be beneficial.
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Collaborating with the company''s local and global RA groups
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Assist departments in identifying, interpreting and implementing applicable regulatory requirements
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Regulatory Affairs representative in product development and enhancement projects
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Contact person for regulatory issues in customer projects
German and English language skills are essential for the immediate work, and certainly beneficial to locally integrating into the community. Hybrid work model is available with 20%-40% flexibility to work from home
This being a replacement role, they are keen to move on it quickly and interviews will be organised at short notice. Those with 3 month Notice Periods will naturally also be considered.
Current Medical devices experience, and even Diagnostics background would be ideal, although this sector does successfully draw from other tightly regulated industries such as Pharmaceutical and Chemical.
If you are interesting in building your career with a well respected company, that''s in a solid growth phase, and offering extensive training and development opportunities, please contact the Senior Consultant Andrew Boroky by applying with your resume in WORD format, plus scanned copies of training certifications and work references.
KEY WORDS:Regulatory Affairs, product licence, registration, regulatory agency inspections, product recalls, German, English, Notified Body, Regulatory compliance, Medical Devices, USA, FDA, ISO 13485, MDR, Research & Development, Medical Device jobs, Austria, Medical Device jobs, nonstop recruitment
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in Switzerland, Luxembourg, the Czech Republic, UK, Romania, and the USA, and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover