Sr. Regulatory Affairs Manager (PR/252578) Hamburg, Germany

Job Type: Sr. Regulatory Affairs Manager

Location: Hamburg
A global leader in the innovative medical device industry, paving the way in discovering treatments for patients within the Ophthalmology industry, the organisation is seeking for a Regulatory Affairs Specialist to join their team. You can have a positive impact on the lives of millions of people around the globe, with the market of ophthalmology looking to surpass £27 Billion by 2023; the growth of products seem to be endless. 

Key Responsibilities of the Sr. Regulatory Affairs

Manager:

• Identifying requirements for registrations and approval processes.
• Conducting regulatory approvals for medical devices and ensuring that current regulatory approvals are maintained.
• Processing International approvals for EU and USA.
• Creating and maintaining important materials within marketing documentation.
• Able to establish and explain in details how documents are processed.
• Lead Regulatory Projects

Key Requirements of the Sr. Regulatory Affairs Manager Include:

• Bachelor/Master degree in sciences, life sciences, engineering, software development or equivalent education gained through work experiences.
• 3/5 years’ experience in Medical device.
• Knowledge in marketing surveillance report.
• Experience in writing product description.
• Medical Device Background.
• Experience within Technical Files.
• Background knowledge in MDR Regulations.

Benefits:

• Competitive benefits and great personal development opportunities.
• Great atmosphere within a vibrant team.
• Learning & Development Support.

 
Please Apply online if you are interested in this opportunity.
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