RA and COMPLIANCE SPECIALIST based in Bucharest (Romania) or Newbury (England) in București at Stryker Corporation

Date Posted: 2/11/2020

Job Snapshot

Job Description

The Job’s Mission

Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Collaborates with clients to develop positive and proactive approaches to regulatory compliance. Participates in good laboratory practices training of functional areas and assists in the development of training sessions. Ensures that privacy and security standards are met and adhered to. May coordinate activities and assist with interactions during regulatory agency inspections

Key Activities & Accountabilities

  • Responsible to monitor and run Product Complaint Handling Process   
  • Raising and closing PERs in a timely manner.
  • Preparing closure letters for customers where appropriate.
  • Following up on open PERs to ensure an effective and efficient complaint investigation can be performed.

Obtaining appropriate supporting information from the customer and Stryker Staff including ensuring customer needs are understood.

  • Facilitate information flow with Stryker Divisions regarding technical information and medical assessments
  • Prepare training materials on customer product complaints and perform WebEx/Skype or in person training to the players in the customer complaints process.
  • Deliver training sessions to any Stryker new on board
  • Prepare regular reports as requested: weekly / monthly reports, support quality management meetings and audits preparation and readiness
  • Active member of EMEA PER team, providing support to colleagues and working towards streamlined, harmonised, best practice PER process across EMEA.  
  • Part of the Stryker local team and EMEA RAQA team

Education

  • Fluent in English
  • Fluency in other European languages would be an advantage
  • Graduated at minimum with a Diploma

Experience

  • Experience of working in QA/RA or in a customer facing role.
  • Proficiency of using Excel and Oracle ERP system.
  • Experience of working in an international business environment minimum 3 years.
  • Knowledge of Medical Device environment & Medical Device regulations will be welcomed.

Competencies

  • Good communication and team working skills.
  • Ability to build relationships across multiple countries and cultures
  • Good report writing skills
  • Excellent attention to detail
  • Analytical & customer service skills
  • Ability to prioritise and organise own workload
  • Ability to analyse data and statistics
  • Ability to work to strict deadlines and under pressure
  • Team player able to embrace new challenges and support other team members

Work From Home: Not available

Travel Percentage: None

CHECK OUT OUR SIMILAR JOBS

  1. Environmental Jobs
  2. Environmental Manager Jobs

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