Job Description
Regulatory Training Administrator
Location: homebased, very occasional travel required
About BSI
BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
Our Medical Devices (or Regulatory Services RS) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands and United Kingdom and is an accredited ISO 13485 Certification Body recognised in many global markets.
Working in close conjunction with the VP Regulatory, Head of MD Notified Body, Head of IVD Notified Body and Head of UK Approved Body, we are looking for a Regulatory Administrator who provides administrative support to the Regulatory Team.
As Regulatory Administrator, you will:
- Monitor and coordinate shared inboxes to ensure timely assignment of tasks to Regulatory Leads
- Monthly / Quarterly reporting
- Support External Document review process, including administration of Steering Group meetings including recording, distribution and follow up of actions
- Support the use of Online Webinar Tools (Webex, MS Teams) hosting sessions
- Undertake general administrative tasks related to regulatory audits, such as listings of attendees/non-attendees and associated follow-up actions; maintenance of distribution lists; maintenance of external documents not held in ENTROPY; preparation of evidence from IT Systems (Pointglobal, DARWIN)
- Communication with and responding to BSI internal customers
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To be a successful Regulatory Administrator, you'll need to:
- Show previous administration experience obtained in a training or similar environment where individuals are continuously tasked to meet time bound objectives
- Understand the principles of document control
- Be able to work as a team and an aptitude for sharing work responsibilities with the ability to multitask
- Be proficient in relation to general IT skills such as Microsoft Word, Excel, PowerPoint
Additionally, it is desirable if you have:
- Understanding of the medical device industry products, BSI Medical Devices CE-marking certification processes, accreditation and Regulatory bodies
- Knowledge of online Webinar Tools (Webex, MS Teams)
- Experience communicating with senior leaders and working remotely
Do you believe the world deserves excellence?
We offer a highly competitive salary with 27 days annual leave with the opportunity to increase this to 32 days, company-paid private medical insurance, an excellent company-contributed pension scheme, and a wide range of flexible benefits that you can tailor to suit your lifestyle.
Job Types: Full-time, Permanent
Benefits:
- Company pension
- Employee discount
- On-site parking
- Private dental insurance
- Private medical insurance
- Referral programme
Schedule:
Supplemental pay types:
Work Location: Remote