Senior Renal Product Development Specialist
4 days ago
Renal Business is seeking a skilled Senior Renal Product Development Specialist to lead projects, tasks, and activities related to product development and lifecycle management of Peritoneal Dialysis products.
Duties and Responsibilities:
- Define, organize, plan, and execute activities related to product design change, supplier-related changes, new product registration, and strategic or value improvement projects in compliance with current international, regional, and national regulations.
- Propose, formulate, and coordinate action plans for the implementation of changes and related activities by working closely with cross-functions, including PDO Organization, Project Management, Regulatory, Quality, and senior colleagues.
- Develop, document, test, and manage product-related changes in accordance with established Renal Care product processes and stay aligned with the Quality Management System.
- Evaluate and ensure good internal and cross-functional communication and regular status updates of activities.
- Establish, maintain, and update Technical Design documentation according to Good Documentation Practices.
- Contribute to ideation sessions for product enhancement and exploratory activities to foster an innovation culture within the team.
- Assist in providing technical support to queries from MOH authorities or auditors in due time by collaborating with cross-functions and subject matter experts.
- Maintain Quality Compliance to Baxter policy, Ethics, Data Integrity, and other relevant policies.
Qualifications:
- Masters in Science or Pharmaceutical disciplines is required.
- Adequate orientation towards Renal PD therapies and products with time.
- Adequate knowledge of product development stages and life cycle management required for effective collaboration with cross-functions and execution of project deliverables.
- Adequate knowledge of Design Control documentation, Process, and Quality Management Systems.
- Adequate knowledge of international, regional, and national regulations and standards.
- Demonstrate Project Management skills in due time.
- Demonstrates flexibility and the ability to shift gears between projects comfortably.
- Excellent oral and written communication skills.
- Good analytical and problem-solving skills.
- Good organizational skills.
- Ability to effectively organize and prioritize tasks.
About Lifelancer:
Lifelancer is a forward-thinking organization that values innovation and expertise. We are dedicated to delivering high-quality products and services that meet the needs of our customers.
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