Job Overview
We are seeking a Principal Regulatory Affairs Specialist to support our regulatory affairs department. This role will be responsible for facilitating the product development process, submissions, and ensuring regulatory compliance.
Main Responsibilities
* Develop and maintain positive relationships with device reviewers through effective oral and written communications.
* Support the implementation of departmental policies and procedures.
* Provide Regulatory Affairs training to cross-functional groups.
* Design and execute regulatory strategies for new and modified medical devices.
* Act as a key member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
Requirements
* A bachelor's degree in a STEM field (regulatory affairs or relevant discipline).
* A minimum of 7 years' experience in Regulatory Affairs or a related field within the medical device industry.
* Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards.
Benefits
This position offers a challenging opportunity to develop your skills and expertise in Regulatory Affairs. If you have a strong background in regulatory compliance and excellent communication skills, we encourage you to apply.