Regulatory Affairs Expert for Medical Devices in Latin America
hace 17 horas
We are seeking a highly skilled Regulatory Affairs Expert to join our team at Olympus Corporation Of The Americas. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements for medical devices in the Latin American region.
Job DescriptionIn this role, you will act as the primary contact for regulatory matters related to new product registration and lifecycle management for assigned product portfolios within the Latin American Region. Your responsibilities will include:
- Evaluating the regulatory environment and providing internal advice throughout the product lifecycle to ensure product compliance.
- Anticipating regulatory obstacles and emerging issues throughout the product/registration lifecycle and developing solutions.
- Requesting, collecting, and reviewing technical/legal documentation from manufacturers to ensure its adequacy to registration requirements in Latin America.
- Preparing, submitting, and coordinating regulatory submissions for new products and product changes as required, while ensuring timely approvals and compliance with regulatory requirements.
- Responding to requests from regulatory agencies and/or distributors to resolve potential regulatory issues and questions.
To succeed in this role, you will need to possess a strong foundation in regulatory affairs, including:
- Bachelor's degree in science, biology, chemistry, or a related field.
- A minimum of 8-10 years of direct experience in regulatory affairs at a medical device company.
- Solid knowledge of Latin America regulatory product registration processes, including class III devices.
- Practical experience in preparing submissions and interacting with regulatory agencies.
- Maintenance of proficiency in applicable regulatory requirements.
Olympus Corporation Of The Americas offers a competitive salary range of $95,000 - $125,000 per year, depending on experience. Additional benefits include:
- Comprehensive medical, dental, and vision coverage.
- 401(k) plan with company match.
- 24/7 Employee Assistance Program.
- Free virtual wellness classes.
- Hybrid work arrangement with remote options.
- 12 paid holidays.
- Parental leave and adoption assistance.
Olympus is a leading medical technology company dedicated to improving clinical outcomes, reducing costs, and enhancing the quality of life for patients. We strive to create a diverse, inclusive, and authentic workplace where empathy and unity thrive.
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