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.