Hybrid Senior Data Entry Specialist bei Cochlear

Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.

The Senior Data Entry Specialist plays a critical role in managing and maintaining high-quality data that supports regulatory compliance and business operations. This includes collecting, verifying, analyzing, and updating data in internal systems, especially data related to Unique Device Identification (UDI) and other regulatory requirements for medical devices.

This role requires close collaboration with global teams such as Research & Development (R&D), Clinical Affairs, Regulatory Affairs, and Quality Assurance to ensure that all data is accurate, complete, and aligned with both internal standards and external regulations. The specialist also provides guidance on data requirements and ensures that data processes are followed consistently.

Key Responsibilities:

UDI Data Collection, Analysis, Management & Maintenance

• Data Collection & Entry.

• Follow established procedures to collect product data required for regulatory submissions and business operations.

• Enter data into the Product Information Management (PIM) system, ensuring accuracy and completeness.

• Regularly review and verify data updates to maintain current and compliant records.

• Ensure data meets regulatory standards such as FDA GUDID, EU EUDAMED, and GDSN.

Cross-Functional Collaboration

• Work with internal teams across multiple global sites to gather and validate data.

• Coordinate with external database vendors to understand system requirements and implement updates.

• Provide timely data to support product launches and regulatory submissions.

• Communicate data needs and changes clearly to internal stakeholders.

Data Publishing

• Collaborate with regional regulatory and quality teams to publish data into official regulatory databases.

• Ensure published data meets both business and legal requirements for each market.

UDI Process Development

Roadmap & Strategy

• Develop and maintain a roadmap for implementing UDI in new markets based on local regulatory requirements.

• Identify gaps and opportunities for improving UDI processes across regions.

Documentation & Procedures

• Assist in creating and updating Standard Operating Procedures (SOPs) and Work Instructions for UDI data collection and maintenance.

• Ensure timely review, approval, and implementation of documentation in collaboration with cross-functional teams.

Regulatory Compliance

• Support the compilation and review of documentation related to product development, manufacturing, and quality assurance.

• Ensure all documentation aligns with UDI regulatory standards and internal policies.

Training & Education

• Provide training sessions to internal teams on UDI requirements and data integrity.

• Promote awareness and understanding of regulatory expectations across departments.

Process Improvement

• Identify inefficiencies in current data workflows and propose improvements.

• Work with IT and business teams to enhance data accuracy and submission processes.

Industry Awareness

• Stay informed about changes in global UDI regulations, standards, and industry best practices.

• Share relevant updates with internal teams to ensure ongoing compliance.

Regulatory Data Management

• Maintain regulatory data in internal systems to support planning and coordination of compliance activities.

• Ensure data is structured and accessible for audits, inspections, and regulatory reporting.

• Monitor data integrity and proactively resolve discrepancies or inconsistencies.

Team Role

• Act as an individual contributor, working independently while collaborating with others.

• Follow quality procedures to ensure data accuracy and compliance.

• Participate in audits and quality reviews when trained.

• Suggest improvements to systems and processes to enhance data management.

• Comply with all safety procedures and report any workplace hazards or incidents.

Required Skills:

• Data Analysis & Interpretation: Ability to read, interpret, and analyze data from multiple sources.

• Attention to Detail: Exceptional accuracy in data entry and validation.

• Decision-Making: Capable of making informed decisions even when faced with unclear or incomplete information.

• Communication: Strong written and verbal communication skills; able to explain data requirements and collaborate effectively.

• Problem-Solving: Good analytical skills to identify and resolve data-related issues.

• Collaboration: Ability to build relationships and work with cross-functional teams.

Desired Skills:

• Experience with regulatory databases such as GDSN, EUDAMED, or GUDID.

• At least 4 years of experience in medical device labeling or UDI compliance.

• Familiarity with evaluating data for compliance with regulatory standards, laws, and industry guidelines.

• Knowledge of medical device regulations, such as FDA, EU MDR, and ISO standards.

Cochlear Malaysia provides shared services to support Cochlear’s global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering.

If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.

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