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Boston Scientific Business Analyst II 
Ireland, Galway 
962376411

05.07.2024

Hiring Manager:Jean Mc Morrow

Closing Date:16th July

About the role:

As a Business Process Analyst, you will play a key role in ensuring the successful Business Transformation across BSC working on process relating to
Distribution product control.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining quality methodologies, systems and practices which meet BSC, customer and regulatory requirements.

Your responsibilities will include:

  • regulatory product control processes and applications.
  • Aligning Requirements, monitoring project plans, communicating with Stakeholders, coordinating the Requirements, Design, Build and Testing Phase and supporting the network-wide Deployment.
  • Represent the business user by working closely with Stakeholders to translate User Requirements into Business User Stories and the ‘Who, What, Why’ Acceptance Criteria.
  • Analyze and translate User Requirements distinctly and assess options before arriving at the aspired solution to improving current systems.
  • Coordinating the User Requirements, aligning to Testing Scenarios, creation of test cases, and execution of test cases to support the Testing Phase and network-wide Deployment.
  • Liaise with the Training team and Site Super Users/ Business Process Leads /Subject Matter Experts to support training plans for each of the key Applications to enhance the knowledge base across relative business teams.
  • Work with the team members and other stakeholders on analyzing the impact of the system change and proper remediation plan for any risks raised.
  • Support with preparing/gathering the documentation and testing of the new system functionalities.

Who are we looking for:

  • Bachelor’s DegreeQuality, Engineering, Science, Computer Science, Business or related field required.
  • 3+ years’ experience or equivalent in a medical device industry, preferably in a regulatory affairs environment.
  • Knowledge of regulatory requirements for medical device industry.
  • Working knowledge of ERP systems combined with knowledge of key business processes.
  • Comprehensive understanding of the MDD/EU MDR, ISO standards.
  • Effective team member, fully motivated to achieve and demonstrate best practices in line with the department & global objectives.
  • Good social and communication skills
  • Strong analytical skills, eager to improve and results oriented.
  • Good knowledge of the English language (verbal and written)

Preferred Qualifications:

  • Medical device industry experience.
  • Regulatory affairs experience in medical device industry.
  • Working knowledge of SAP S4Hana service management and/or quality processes which covers data management is an advantage, but not essential.
  • Gathering, analyzing, and interpreting data to understand gaps and risk assessment.
  • Previous experience of a major program introduction/upgrade, ideally within an IT/Systems or Business representative role is an advantage, but not essential.
  • Sense of urgency and commitment to execution.