Compliance Administrator at Seer Medical

Hospital & Health Care, Administrative, Full-time, Melbourne, Victoria, Australia melbourne full-time
Description
Posted 21 days ago

About Us

Seer is developing technology to revolutionise the diagnosis and management of neurological conditions, with a special focus on epilepsy. Our mission is to deliver deep personalised clinical insights and advance patient experience with leading-edge technology.

Our technology consists of wearable devices, a cloud platform and machine learning systems. These systems are at the core of our at-home video-EEG-ECG monitoring and diagnostic service - the first of its kind. Seer has already made a big impact across Australia over the last three years and is now building for international expansion.

About The Role

We are seeking a Compliance Administrator to develop and manage the compliance processes that reviews and evaluates compliance issues. You will be joining our small Regulatory and Compliance team to ensure that our manufacturing operations follow all relevant compliance requirements and scope while meeting business objectives.

Your responsibilities will include:

  • Contributing to the development and review of standard operating procedures and related policies and Quality documentation.
  • Participating in internal audits and maintaining the internal audit schedule.
  • Investigating and resolving non-conformances and maintenance of related QMS records.
  • Delivering QMS and SOP training for the QMS and maintain the company training matrix.
  • Compiling the monthly/quarterly Quality Metrics reports for the monitoring of the QMS Planning and compilation of Management Review documentation.
  • Performing data analysis and trending where necessary.
  • Supporting document control process and maintain the appropriate quality records.
  • Assisting in customer complaint handling processes and the documentation of the process stages and complaint resolution.

To be successful in this role you will have:

  • Experience with one or more of the Medical device quality systems such as: ISO 13485, ISO 9001, GMP, or FDA 21 CFR820.
  • A background in manufacturing with a good understanding of risk management processes and the application in a manufacturing environment.
  • Demonstrated knowledge of auditing processes and training as an internal QMS auditor.
  • Good communication skills – written and verbal.
  • Ability to manage time within a fast growth environment.
  • Experience in IT systems, information security standards (ISO 27001) and data compliance regulations (GDPR, HIPAA, Australian Privacy Act) is desirable.
  • PC Skills in Microsoft Word, Excel, and PowerPoint. Experience with Greenlight Guru, SAP Litmos, and Fishbowl IMS are highly desirable.

What We Offer

  • An opportunity to work with the best of the best, solving life-changing problems in healthcare
  • Joining a dynamic company at a time of major growth and international expansion
  • Professional development and career growth
  • Working in an inclusive environment that promotes diversity
  • Competitive salary

At Seer, we are committed to creating a diverse team whose members help each other to grow. For this reason, we encourage women and people from minority groups to apply for jobs with us.