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.
