Job Overview:
Our client is seeking a Regulatory Affairs Specialist to join their team. This role will be responsible for ensuring compliance with regulatory requirements and maintaining relationships with relevant authorities.
Key Responsibilities:
* Ensuring compliance with medical device regulations (MDR) and ISO 13485 standards
* Coordinating audits and assessments to maintain CE marking and FDA certification
* Developing and implementing quality management systems in accordance with MDSAP guidelines
Requirements:
* Experience working with medical device regulations, including MDR and ISO 13485
* Proven track record of ensuring compliance with regulatory requirements
* Strong communication and interpersonal skills
About the Role:
This is an onsite first role with some flexibility for remote work in the future. The successful candidate will have the opportunity to work with a life science business that manufactures equipment for the global market.
How to Apply:
To discuss this opportunity further, please send your up-to-date CV in response. We will be in touch at the earliest opportunity.