Our company is seeking a highly skilled Regulatory Affairs Specialist to ensure compliance with global regulatory requirements for medical devices.
We require the successful candidate to develop and maintain positive relationships with device reviewers through oral and written communications, assist with policy implementation, provide Regulatory Affairs feedback throughout the product development cycle, and prepare and submit regulatory applications.
The ideal candidate will have a Level 8 Bachelor's Degree in a STEM field, such as regulatory affairs or a related discipline, and a minimum of 7 years experience in Regulatory Affairs or a related discipline within the medical device industry.
The successful candidate will be required to demonstrate proficiency with relevant US/EU regulatory requirements for medical devices, including Quality Systems standards, and prior experience with a variety of regulatory submissions for US and EU MDR.
We are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.