Regulatory Affairs Specialist
hace 4 semanas
We are seeking a highly skilled Regulatory Affairs Specialist 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 Latin America.
Key Responsibilities:
- Evaluate the regulatory environment and provide internal advice throughout the product lifecycle for marketed devices to ensure product compliance.
- Anticipate regulatory obstacles and emerging issues throughout the product/registration lifecycle and develop solutions.
- Prepare, submit, and coordinate with RA Consultants or Distributors regulatory submissions for new products and product changes as required in accordance with established timelines and submission dates to ensure timely approvals while in compliance with regulatory requirements and guidelines.
- Respond to requests from regulatory agencies and/or distributors to resolve (potential) regulatory issues and questions to continue evaluations of product submissions.
- Maintain the product registration and documentation RA databases.
- Monitor the progress of the regulatory authority review process through appropriate communications with the RA Consultants, Distributors, and reporting out to Business Units as needed.
- Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
- Assess change requests from the legal manufacturer for compliance with regulatory requirements and government submissions.
- Provide support to currently marketed products as necessary.
Requirements:
- Bachelor's Degree in science, biology, chemistry, or a related field.
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
- A minimum of 8-10 years direct experience in regulatory affairs at a medical devices or pharmaceutical company.
- Solid knowledge of Latin America regulatory product registration processes, including class III devices.
- Practical (hands-on) experience in a medical device regulatory environment preparing submissions.
- Experience interacting with regulatory agencies.
- Maintain proficiency in applicable regulatory requirements.
- Project management experience highly preferred; experience with prioritizing multiple tasks and driving results.
Why Olympus?
We are a company that cares about people's lives and health, including yours. We inspire healthier lives, together. Our purpose is to make people's lives healthier, safer, and more fulfilling. Our core values are reflected in all we do: Integrity, Empathy, Agility, Unity, and Long-Term View. We deliver on our purpose and our core values by staying True to Life.
We offer a competitive salary, annual bonus, and 401(k) with company match. We also provide comprehensive medical, dental, and vision coverage, as well as a 24/7 Employee Assistance Program. We offer free virtual live and on-demand wellness classes, work-life balance supportive culture with hybrid and remote roles, and 12 paid holidays. We also offer educational assistance, parental leave, and adoption assistance.
We are dedicated to building a diverse, inclusive, and authentic workplace. We recognize diversity in people, views, and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
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