RA Specialist II
Olympus Corporation of the Americas
Summary
Assist the Manager Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus.
Job description
Job Duties
- Participate in product teams developing new products. As needed, provide input to define global regulatory strategy requirements.
- Participate in teams for sustaining products to provide input on global regulatory requirements.
- Where designated, develop, coordinate, prepare and maintain US medical device submissions such as 510ks and Pre-Submissions and liaise with FDA reviewers as needed.
- Where designated, develop, coordinate, prepare and maintain medical device submissions for Canadian Class 2, 3 or 4 Device License submissions.
- Respond to regulatory authorities' requests for additional information.
- Where designated, interface with the EU Submissions Team to support preparation of dossiers and technical files for registration of Olympus products in the EU.
- Where designated, interface with International Regulatory Affairs Team to support preparation of dossiers for registration for other international markets such as Japan, the Far East, Australia and Latin America.
- Assist with maintenance of regulatory files and databases to ensure prompt and accurate access to company regulatory information.
- Provide dashboard updates concerning current, pending and future approvals for Regulatory Affairs management.
- As needed, assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
Requirements
- Regulatory affairs experience in the Medical Device industry is mandatory
- Minimum 3 years with BS/BA or 1 year with MS
- BS/BA required preferably in engineering or life sciences
- RAC accreditation a plus
Benefits
- Competitive salaries
- Annual bonus
- 401(k) with company match
- Medical, Dental & Vision
- Employee Assistance Program
- Wellbeing Programs
- Paid Vacation
- Sick Time
- Paid Parental Leave
- Adoption Assistance
- Paid Holidays
- On-Site Child Daycare
- Café
- Fitness Center
- Paid volunteering
- Charitable donation match
- Employee Resource Groups
- Training Resources
- Learning & Development Programs
- Paid Educational Assistance
Company overview
Olympus Corporation of the Americas is a leading global medical technology company and a wholly owned subsidiary of Olympus Corporation, headquartered in Center Valley, Pennsylvania. As a pioneer in the medical device industry, Olympus specializes in developing and manufacturing advanced endoscopic solutions, minimally invasive surgical equipment, and diagnostic imaging systems. The company holds approximately 70% of the global endoscope market, with a comprehensive portfolio that includes gastrointestinal endoscopes, laparoscopes, bronchoscopes, urological devices, and video imaging platforms. With over 5,200 employees across North and South America, Olympus focuses on creating innovative medical technologies that enable early detection, diagnosis, and minimally invasive treatment of diseases. The company's products are used across multiple medical specialties including gastroenterology, pulmonology, urology, and general surgery, helping healthcare professionals improve clinical outcomes while reducing procedural costs. Olympus continues to invest heavily in research and development, digital healthcare solutions, and AI-powered diagnostic tools to maintain its leadership position in the medical technology sector.