Regulatory Affairs Manager

Position Description:

Ceribell is looking for a Regulatory Affairs Manager to work with internal and external partners to deliver innovative healthcare solutions to patients. This role will assist development teams in the design of new or updated products by providing regulatory insight and strategic support through all phases of the product lifecycle. This role will be responsible for the drafting of submissions to regulatory authorities and subsequent follow-up to any requests for additional information. The ideal candidate should have a solid background in medical device regulatory affairs, excellent interpersonal communications, and a problem-solving mindset. 

Responsibilities:

• Manage regulatory strategy and submissions for key product initiatives
• Collaborate cross-functionally to compile, review, and submit regulatory submissions to authorities and respond to subsequent requests for information
• Develop documentation to satisfy CE Mark maintenance requirements as specified by the EU MDR
• Advise development teams on product design strategy as it relates to regulatory pathways and compliance
• Effectively communicate regulatory strategies and progress to internal stakeholders
• Identify applicable standards, regulations, and FDA guidance documents and assist in their interpretation and resulting compliance strategies.

Requirements/Qualifications

• 4-6 years of experience in medical device regulatory affairs (consulting experience preferred)
• Bachelor's degree in a biological, scientific, or engineering field (Master's preferred)
• Direct experience in drafting medical device submissions
• Experience interacting with regulatory authorities
• Ability to work collaboratively in a fast-paced environment while managing multiple priorities.