RAQA Assistant

We have an exciting opportunity for a hard working, self driven person to join our growing team as RAQA Assistant.

Reporting to the Director of QARA, the successful candidate will be responsible for coordinating critical RAQA affairs activities within B-Secur.

The Role

The Regulatory Affairs Coordinator/Assistant will be responsible for the following activities:

  • Support the implementation, adherence and schedule relating to the RAQA SOPs for record and change control;
  • Support updates to RAQA SOPs, work instructions, and policy documents to support an ePLM in compliance with MDSAP and EU-MDR;
  • Support Training co-ordination;
  • Support technical documentation file coordination internally and externally;
  • Support internal/external audit documentation and general coordination;
  • Creation and distribution of communications to the site and division and various other internal/external audiences;
  • Supporting resource management coordination;
  • Assistance coordinating presentation and report creation; ensuring compliance with brand requirements;
  • Coordinating developmental activities including site visits, CSR activities, team building and leadership offsite activities;
  • Scheduling regular meetings and coordinating calendars with other administrative support staff, book venues and refreshments, assisting with distribution of meeting agendas;
  • Represent B-Secur and the Leadership team when liaising with internal and external customers to organise conferences, meetings and large-scale events;
  • Other duties as required

Qualifications, skills and experience

  • The person should demonstrate the following experience, skills and behaviours
  • Engineering or Science or an equivalent qualification preferred
  • Minimum of 12 months’ experience in a regulated industry preferred
  • An understanding of ISO 13485: 2016 preferred
  • An understanding of MDSAP and EU-MDR regulations would be advantageous
  • Knowledge of 21 CFR part 820 preferred
  • Knowledge of ISO 14971 and ISO 14155 would be advantageous
  • Previous record and change control experience would be advantageous
  • Basic Microsoft Office, MS Project, Adobe Acrobat
  • Effective Communication Skills
  • Highly developed technical writing skills
  • Highly developed decision-making skills

Location

It is likely that this role will involve both working in the office based in Belfast and working from home as well as occasional travel to other locations as required.

What can B-Secur offer you?

This is an exciting opportunity to join a growing business as we further our mission to revolutionise the way people experience technology in the connected world, every day, by using their unique heartbeat.

As well as a competitive remuneration package with enhanced benefits, we offer:

  • A fun, relaxed, and collaborative environment, working in a company built on honesty and trust;
  • Full flexible working to enable you to maintain a healthy work life balance;
  • Joining a growing company that's evolving all the time, giving you the opportunity to test yourself and your role to discover your skills;
  • Being surrounded by a group of bright, motivated people. We are a friendly, straightforward, and talented bunch that keeps it light-hearted;
  • Opportunities for you to grow your professional competence and personal development.

Apply Now

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