RAQA Specialist - 25067BR - EN in Newbury at Stryker Corporation

Date Posted: 5/8/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Newbury
  • Job Type:
    Regulatory Affairs
  • Experience:
    Not Specified
  • Date Posted:
    5/8/2018
  • Job ID:
    25067BR

Job Description

Key Activities & Accountabilities:

(Note: In addition to these activities employees are required to carry out such other duties as may reasonably be required)
  • Ensure Stryker UK meet their Post Market Surveillance and Vigilance requirements as laid down in the Medical Device Directive/Regulation and associated guidelines, in relation to (but not exclusively) product complaints, product holds and product field actions.

  • Enter received product complaints into the Trackwise database. Ensure the complaints/adverse events are reported according to the MEDDEV guidelines.

  • Follow up on open product complaints to ensure an effective and efficient complaint investigation can be performed. Obtaining appropriate supporting information from the customer and Stryker employees.

  • Review product complaint investigations and prepare customer responses according to Stryker standards.

  • Active member of the European Product Complaints team, providing support to colleagues and working towards streamlined, harmonised, best practice across Europe.

  • Review and monitor the Key Performance Indicators (KPIs) for PMS and report potential trends.

  • Effectively execute field safety corrective actions (FSCAs) according to the Regulations and SOPs. ​

  • ​​Liaise with European RAQA Team and Manufacturing sites to expedite the timely closure of actions relating to above mentioned areas.

  • Work with relevant parties to ensure timely response to requests for information/action from the UK and Irish Competent Authorities.

  • Support continued compliance of Stryker UK with the ISO9001 standard through internal audit programme, process improvements and participation in external BSI audit.

  • Provide support and advice to all levels within Stryker UK on European / local regulatory requirements and how the business can meet them.

  • Provide support to the Benelux and Nordic regions during holiday/busy periods.



Position in structure

  • Member of UK RAQA Team reporting directly to RAQA Manager UK & BeneNord


Equipment / software packages used:

  • Microsoft Suite (Outlook, Excel, Word, PowerPoint).
  • Oracle, Trackwise, SharePoint, Skype for Business, GIM

Working conditions / degree of effort required:
  • Office based ~ 99%
  • Travel required ~ 1% (Occasional team / intercompany / customer meetings)

Job Requirements

Qualifications / education required:
  • Degree educated or equivalent
  • Scientific, Engineering or law background preferable (but not essential).


Experience required:
  • Minimum 1 year experience in Medical Device Regulatory Affairs/Quality Assurance
  • Knowledge of the Medical Devices Directive and associated local laws.
  • Knowledge of Quality Management System Standards preferred e.g. ISO9001, ISO13485
  • Experience of interaction with Competent Authorities / Notified Bodies


Any other particular aptitude / skill required
  • Excellent spoken and written English
  • Ability to effectively communicate with end customers and all areas/ levels of the business
  • Excellent attention to detail and high degree of accuracy when analysing and compiling documentation / data
  • Flexible, 'can do' attitude
  • Capable of working on many projects simultaneously.
  • Ability to prioritise and organise own workload.
  • Able to work to strict deadlines and under pressure.
  • Teamwork capability

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