Global Regulatory Affairs Manager (m/d/f)

Tasks:

• Provide input into and support for the execution of the global regulatory strategy for medical devices Ensure that products and their documentation continuously meet regulatory requirements for US, EU, Japan, and other key markets
• Drive product group-specific interactions with local regulatory authorities / notified bodies, acting as a point of contact between - Olympus and regulatory authorities / notified bodies as required
• Support sustaining activities for launched products globally
• Partner with other Olympus functions (e.g., R&D) across the product lifecycle to ensure consideration of regulatory requirements

Qualifications:

• Bachelor’s degree in Engineering, Medical or Science (or similar) is required. Master’s degree preferred
• Three years experience in Regulatory Affairs in a Medical Device Industry
• Experience in designing, writing and submitting of regulatory filings (e.g., 510(k), CE Mark etc.) and correspondence is required
• Strong written and verbal communication skills in English. German is an advantage
• Knowledge in project management
• Strong IT skills - experience utilizing a relevant regulatory system (desirable, e.g., RIM / PLM) and basic Office applications

Benefits:

• Employee restaurant (subsidized)
• Christmas Bonus & Holiday Pay
• Flexible Working Time
• Bike leasing (JobRad)
• 30 days of holiday
• Up to 60 % mobile working possible

Apart from Germany, we have multiple work locations in the EMEA region. We offer hybrid models but mostly remote options are also an option. The reference number is 80040046-11052023.