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Regulatory Assurance Specialist (part time)

We’re Eargo and we’re on a mission to disrupt and transform the hearing health industry! We’re looking for passionate individuals who jump out of bed in the morning dreaming of new ways to improve the lives of our customers.

We’re tech geeks and dreamers. We believe that every voice is unique and every idea is worth talking about. Moreover, we believe in passion and having fun. Because it takes passion to change the world and if you have passion in what you’re doing, you naturally have fun doing it. But, we do have a serious side. Over 48 million Americans currently experience hearing loss and 80% of them do nothing about it. More often than not it’s related to social stigma. This is why we exist…to give people their hearing without the social stigma so that they can go on being the cool person they are. That’s why we get out of bed in the morning and we take that seriously.

Does this sound like a place you want to work? Well, you’re in luck! We’re looking for some great minds to join us on our journey.

We are seeking a team oriented, driven and self-starter specialist to join the RAQA Team working part time. The Regulatory Assurance Specialist will be responsible for US regulatory activities. Work with Management on Regulatory Affairs to develop and implement strategies that will ensure the timely introduction of product into the US and other markets. If required, participate in interactions and discussions with Regulatory Agencies to resolve issues arising during the regulatory submission review process to ensure a timely approval process. This position will also ensure compliance of the organization to key quality systems level functions such as CAPA management, internal & external audits.

 

This is what you’ll be doing:

  • Co-Host and Co-lead all external audits with Notified Bodies, FDA, FDB. Respond to all corrective actions in a timely manner and drive all issues to closure. 
  • Conduct internal audits to ensure compliance with all quality standards.
  • Ensure timely closure of the CAPAs
  • Work with clinical in preparation and reporting of MDR Adverse events/vigilance reporting
  • Work with cross-functional teams in preparation of regulatory filings
  • Interact with FDA/Notified Bodies/ Foreign Regulatory / State-by state agencies to understand market requirements, resolve issues and satisfy all requirements.
  •  Prepare regulatory plans/strategies for new and modified products in across multiple locations
  • Review product labeling, advertising and promotional materials as required for conformance with applicable regulations
  • Regulatory review of internal documents as CCB member
  • Gather information, provide detailed reporting and provide management with key updates, including Management Review. Assist in the closure of action items from Management review

This is what we’re looking for:

Must-have’s

  • Must have minimum 5-8 years experience in medical device design and manufacturing environment
  • Must have practical and working knowledge of ISO 13485, 21 CFR 820
  • Must have proven track record with regulatory filings and understanding market requirements
  • Must have experience with electronic reporting of MDR
  • Must be detail oriented, well organized and have excellent communication skills
  • Must work well with cross-functional team and all levels of the organization
  • Must be able to accomplish objectives with minimal supervision
  • BS Degree or higher in life sciences or engineering

Nice-to-have’s

  • Self-starter who is capable of taking innovative initiatives
  • Experience with startup companies
  • Experience with Omnify, or the equivalent in other PML systems
  • Experience with Salesforce system

 

Does this sound like you? 

If so, let’s talk.

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