Olympus Corporation of the Americas
Olympus Corporation of the Americas is a company dedicated to developing and delivering advanced medical technology solutions aimed at enhancing healthcare throughout the patient pathway. Their mission, encapsulated in the philosophy 'True to Life', focuses on improving the standard of care to empower individuals to lead fulfilling lives. Olympus offers a range of medical systems and is also involved in educational programs to support clinical expertise and procedural skills enhancement.
5001 - 10000 employees
🧬 Biotechnology
Senior Specialist, Regulatory Affairs
5 days ago
Olympus Corporation of the Americas
Olympus Corporation of the Americas is a company dedicated to developing and delivering advanced medical technology solutions aimed at enhancing healthcare throughout the patient pathway. Their mission, encapsulated in the philosophy 'True to Life', focuses on improving the standard of care to empower individuals to lead fulfilling lives. Olympus offers a range of medical systems and is also involved in educational programs to support clinical expertise and procedural skills enhancement.
5001 - 10000 employees
🧬 Biotechnology
📋 Description
• The role is responsible for the preparation of submission documents for product registration in selected global markets. • The individual acts as an SME in international regulatory affairs and will provide international regulatory expertise in new product developments and sustaining initiatives. • Additional responsibilities may include taking part in cross-functional projects, change management, process development, maintenance and mentoring junior staff.
🎯 Requirements
• BS/BA required preferably in engineering or life sciences, or advanced degree and/or other relative experience • Minimum 5 years prior regulatory affairs experience in the medical device industry • Working knowledge of medical device regulatory requirements outside of the US is preferred • Excellent written and verbal communication skills • Ability to work in cross-functional teams • Attention to detail • Strong organizational skills • Supervise and mentor junior staff • Previous experience working in a global environment; demonstrated sensitivity to cultural differences
🏖️ Benefits
• Competitive salaries, annual bonus and 401(k)* with company match • Comprehensive medical, dental, vision coverage effective on start date • 24/7 Employee Assistance Program • Free live and on-demand Wellbeing Programs • Generous Paid Vacation and Sick Time • Paid Parental Leave and Adoption Assistance* • 12 Paid Holidays • On-Site Child Daycare, Café, Fitness Center**
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