Senior Regulatory Affairs Specialist at PENTAX Medical Americas

The Senior Regulatory Affairs Specialist role at PENTAX Medical Americas is crucial for ensuring that the company's medical devices comply with all relevant regulations in the Americas region. This position requires a deep understanding of regulatory requirements and the ability to navigate complex submission processes. The specialist will be responsible for developing and implementing regulatory strategies, preparing and submitting documentation to regulatory authorities, and maintaining compliance throughout the product lifecycle. This role involves close collaboration with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure that products meet regulatory standards and market access objectives. This is a strategic position that demands strong analytical skills, excellent communication, and a proactive approach to regulatory affairs. The Senior Regulatory Affairs Specialist will play a key role in bringing innovative medical devices to market while upholding the company's commitment to quality and patient safety.