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

Date Posted: 5/8/2018

Job Snapshot

  • Employee Type:
  • Location:
  • Job Type:
    Regulatory Affairs
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

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

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team