Regional Ra Operation Lead, Apj

5 days ago

Singapore Johnson & Johnson Full time

Job Purpose
- Implement and lead development of programs that will support APJ Vision RA team digital transformation roadmap.
- Partner with the regulatory affairs team as well as cross functional stakeholders to build and drive digital solutions that will support workflow and strategy optimization.
- Responsible for the day-to-day processing and validation of data sources both internally and externally to drive regulatory processes and reporting.
- Responsible for supporting continual RA process improvement that can be effectively used within APJ region across all businesses to improve efficiency of the RA organization while maintaining the quality levels necessary for medical device product development and support.
- Support the RA Business Process Owner model and manages teams proactively to ensure alignment and consistency with business strategy and to drive measurable process improvements for the APJ RA organization

Major Accountabilities:

- Identify, prioritize and coordinate process improvement initiatives to improve the speed and cost effectiveness of the APAC RA organization, while maintaining quality levels required for medical device development and support.
- Responsible for maintenance of RA procedures, work instructions, and/or job aids in coordination with the process owners.
- Support development, implementation, and maintenance of RA metrics to help drive performance.
- Maintain the product complaints database and any other regulatory systems.
- Develop, Update and Maintain Regulatory Affairs Sharepoint site.
- Support any regulatory affairs operation activities
- Any assigned projects from APJ RA team

**QUALIFICATIONS**:
Qualifications:
**Education**:

- University degree in Medical Science
- Advanced degree in Medical Sciences preferred

**Experience**:

- Excellent communication
- Knowledge/fluency of at least one additional language preferred
- Strong MS. Excel skills
- Strong problem-solving skills
- Ability to work independently, under pressure, meeting tight deadlines, demonstrating high level of initiative and flexibility.
- Good interpersonal and communication skills and ability to manage effectively in an international environment.

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