Regulatory Affairs Manager

Regulatory Affairs Manager

Location: Berlin, Germany (Onsite)

Overview:

Our client’s mission is to protect the eyesight of patients with retinal diseases. Their unique laser therapy system sets a new standard for retinal treatment. As a leader in innovation, they work to expand continuously into new application areas.

Benefits:
 

1. Attractive Remuneration: Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work.
2. Work with Management: This position allows you to collaborate directly with the Head of Regulatory Affairs and other leaders of the business
3. Fantastic Growth & Learning Opportunities: The team actively encourage you to grow and develop and working within a small RA team will allow you to have exposure to all aspects of regulatory affairs.
4. Permanent Full-Time Position: Permanent employment with secure future prospects.
5. Company pension scheme and other tailored benefits.
6. Responsible and varied tasks that allow you to have an interesting and varied job.
7. Team Events; annual summer and Christmas team events.

Tasks:
 

• Successfully approving medical devices in the US (Class II), Europe (Class IIb), and other markets is your job. You will collaborate closely with the development team and other stakeholders to make improvements to products that are already on the market.
• In compliance with regulations, gather, compile, and keep track of documentation for US FDA 510k submissions, EU MDR Technical Files, and other regulatory submission documents for new medical device registrations and modifications to current products.
• Evaluate and submit changes for international regulatory approvals
• Monitor new legislations, policies, standards and guidelines that affect the assigned product portfolio.
• Conduct post-market surveillance and report adverse events/field safety corrective actions to the authorities
• Communication with Notified Bodies, US FDA and other authorities world-wide
• Support internal and external audits
• Deputy PRRC
• You will report to the Head of Regulatory Affairs

Your Profile:
 

• Completed higher degree in Engineering or Natural Sciences, or sufficient professional experience in the RA field
• Minimum 3 years experience with Regulatory Affairs for Medical Devices (preferably with Active Devices and/or SAMD)
• Knowledge of EU MDR 2017/745 (or EU IVDR 2017/746), US FDA, and further jurisdictions are an advantage
• Successful submission and clearance achievement with the US FDA
• Experience compiling and maintaining technical documentation
• Other processes such as Post Market Surveillance, Vigilance, Usability and Risk Management are an advantage
• Excellent writing and communication skills in English,
• B2 German Language or better

For more information, please contact Luke Fines:
luke.fines@adaptivelifescience.com
+49 30 1663 4514