Specialist, Commercial Quality & Regulatory Affairs
Location
Singapore
Posted
2 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Specialist, Commercial Quality & Regulatory Affairs
Danaher Corporation
Role Description The Specialist, Commercial Quality & Regulatory Affairs will prepare regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals. This individual will represent RA on project core teams, coordinate and prepare document packages for regulatory submissions from all areas of the company as well as for internal audits and inspections. - Compile all materials required in submissions, license renewal, and annual registrations. - Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. - Keep abreast of changes of new or updated regulatory policies and issued guidance. This position reports to the Senior Manager, Commercial Quality & Regulatory Affairs and is part of the Center of Excellence located in Singapore and will be fully remote. In this role, you will have the opportunity to: - Lead pre-market and post-market regulatory activities for IVD devices, including preparation and submission of technical documentation, regulatory applications, change notifications, renewals, and responses to regulatory bodies and partners. - Maintain and manage regulatory intelligence and compliance at local, regional, and global levels, ensuring adherence to applicable regulations throughout the product lifecycle. - Oversee quality management processes and continuous improvement, including compliance operations, audits, CAPA, distributor and warehouse oversight, and acting as Quality Management Representative (QMR) when required. Qualifications - Bachelor’s degree with 2+ years of relevant experience or a certificate in medical devices with 2 years of experience or 3+ years of experience in the medical devices or a related industry. - Understands Regulatory Affairs concepts and is familiar with regulations/guidelines governing the development of diagnostic products. - Ability to prioritize, multitask, and organize work, succeed in a fast-paced environment with capability to be flexible and adaptable to meet business needs. Requirements - Ability to travel – 10%. Benefits - Comprehensive, competitive benefit programs that add value to our lives. - Flexible, remote working arrangements for eligible roles.
Related Guides
Related Job Pages
More Customer Retention Specialist Jobs
• Educate Clients: Provide comprehensive information about the Beyond Finance financial hardship debt program to clients, ensuring they have a clear understanding of the benefits, process, and available options. • Empathize and Deescalate: Display empathy and active listening skills to understand and deescalate upset clients, addressing their concerns and alleviating their stress regarding their financial situation. • Navigate CRM System: Effectively use our Customer Relationship Management (CRM) system to quickly access and comprehend client information, including their current financial status and program progress. Maintain accurate and detailed records of all client interactions and program progress in the CRM system. • Analyze Financial Situation: Assess the client's current financial situation and determine the most appropriate options to help them achieve their goal of becoming debt-free. • Retain Clients: Collaborate with clients to develop customized solutions that align with their financial goals, and encourage them to remain in the Beyond Finance program. • Achieve Retention Goals: Meet or exceed retention targets and earn commissions based on your ability to enable clients to achieve their financial objectives. • Above all else, provide a best-in-class customer service experience over the phone and through various communication tools responding to client requests and anticipating unstated needs
• Provide comprehensive information about the Beyond Finance financial hardship debt program to clients • Display empathy and active listening skills to understand and deescalate upset clients • Effectively use our Customer Relationship Management (CRM) system • Assess the client's current financial situation and determine appropriate options • Collaborate with clients to develop customized solutions • Meet or exceed retention targets and earn commissions • Provide a best-in-class customer service experience over the phone and through various communication tools
• Educate Clients: Provide comprehensive information about the Beyond Finance financial hardship debt program to clients, ensuring they have a clear understanding of the benefits, process, and available options. • Empathize and Deescalate: Display empathy and active listening skills to understand and deescalate upset clients, addressing their concerns and alleviating their stress regarding their financial situation. • Navigate CRM System: Effectively use our Customer Relationship Management (CRM) system to quickly access and comprehend client information, including their current financial status and program progress. Maintain accurate and detailed records of all client interactions and program progress in the CRM system. • Analyze Financial Situation: Assess the client's current financial situation and determine the most appropriate options to help them achieve their goal of becoming debt-free. • Retain Clients: Collaborate with clients to develop customized solutions that align with their financial goals, and encourage them to remain in the Beyond Finance program. • Achieve Retention Goals: Meet or exceed retention targets and earn commissions based on your ability to enable clients to achieve their financial objectives. • Above all else, provide a best-in-class customer service experience over the phone and through various communication tools responding to client requests and anticipating unstated needs.
• Provide comprehensive information about the Beyond Finance financial hardship debt program to clients, ensuring they have a clear understanding of the benefits, process, and available options. • Display empathy and active listening skills to understand and deescalate upset clients, addressing their concerns and alleviating their stress regarding their financial situation. • Effectively use our Customer Relationship Management (CRM) system to quickly access and comprehend client information, including their current financial status and program progress. Maintain accurate and detailed records of all client interactions and program progress in the CRM system. • Assess the client's current financial situation and determine the most appropriate options to help them achieve their goal of becoming debt-free. • Collaborate with clients to develop customized solutions that align with their financial goals, and encourage them to remain in the Beyond Finance program. • Meet or exceed retention targets and earn commissions based on your ability to enable clients to achieve their financial objectives. • Above all else, provide a best-in-class customer service experience over the phone and through various communication tools responding to client requests and anticipating unstated needs
