Remote Regulatory Affairs Manager

Job Summary

A healthcare company needs applicants for an opening for a Remote Regulatory Affairs Manager.

Individual must be able to fulfill the following responsibilities:

• Develop and execute regulatory plans for complex projects
• Monitor applicable regulatory requirements
• Ensure regulatory strategies are aligned with business objectives and project scope

Required Skills:

• Successful preparation and submission of 510(k)s and international documents or registrations
• Scientific and sound regulatory knowledge
• Ability to manage complex projects and timelines in a matrix team environment
• Strong oral and written communication and presentation skills
• Excellent writing skills to develop clear and logical information and conclusions
• Ability to independently identify compliance risks and escalate when necessary