Post Market Quality Manager, Greater Asia

**Job Description Summary**: The talent is responsible for providing the framework for the standardization, harmonization and governance of key post-market activities such as Adverse Event Reporting, Field Actions/Recalls within the GA region for all BDX business units in line with regional regulators & global company regulatory requirements, quality management and management controls.

You will work with the GA Country Quality & Compliance leaders, global MDR (Medical Device Reporting) process Network leader, global Regulatory Compliance Network leader, Field Action global process owner (GPO) and, has responsibility for regulatory compliance standards across all countries in Greater Asia.

**Who We Are**:
**Job Summary**:
The talent is responsible for providing the framework for the standardization, harmonization and governance of key post-market activities such as Adverse Event Reporting, Field Actions/Recalls within the GA region for all BDX business units in line with regional regulators & global company regulatory requirements, quality management and management controls.

You will work with the GA Country Quality & Compliance leaders, global MDR (Medical Device Reporting) process Network leader, global Regulatory Compliance Network leader, Field Action global process owner (GPO) and, has responsibility for regulatory compliance standards across all countries in Greater Asia.

**Main Responsibilities**:

- Oversee the post market quality compliance activities within the GA region, with special attention to the management of complaint-adverse event reporting where applicable; Field Action execution and, establishing and maintaining escalation process, relevant controls and feedback systems to monitor Regulatory Compliance (RC) operation in the Region.
- Engage and establish relationships with the relevant Regulators, Government agencies, policy makers, trade associations, customers, and key opinion leaders, as necessary or as requested within the Region. Where applicable, actively participate in any working groups with the objective to analyze and influence new regulations / market trends within the Region.
- Establish a relationship with the Regulators, Government agencies representing BD for MD/IVD product query or other queries relating to BD activities and/or products within the Region, in conjunction with the respective country Quality & Compliance leaders. Provide support to the GA countries in managing and responding to local Regulator/Government agencies queries/requests.
- Engage and establish relationship with the respective Leadership teams and functions within the Region and, provide periodic reports/scorecards for management controls and other stakeholders as necessary or as requested to track regional-specific performance and goals.
- Provide support to the region BDX business units in relation with the needs of their customers, which may include visits to customer sites relating to matters within Quality/Regulatory Compliance scope.
- May act as “management representative” for liaison with regulatory authorities and customers in ensuring effective resolution or outcome.
- Responsible for sensing, analyzing trends & impact, interpreting new/revised regulatory requirements and develop internal procedures and response plan as required to ensure continuous compliance.
- Builds an influential and effective Network and communication with stakeholders in driving overall site performance, developing, and building a strong culture of Quality, Post Market Quality Compliance and Continuous Improvement.
- Pursue and maintain functional knowledge of relevant regional and global regulations.
- Responsible for monitoring and implementing escalation process & resolution for Late Medical Device Reports caused or contributed by late entries by GA region.
- Assuring adequacy and effectiveness of investigations and Corrective/Preventive Action related to internal failures, field actions, implementation of process improvements (eg, Six Sigma, Lean).
- Strongly employ best practices, continuous improvement, and IT tools to accelerate Quality excellence with respect to regulatory requirement and quality management & management controls perspective.
- Responsible for reviewing, documenting updates and conducting training when necessary, the BD’s quality documents in accordance with quality related regulations, etc.
- Represent GA region in Global Quality/RC Networks and lead GA PMQ/Compliance Network, etc.
- Conduct/support quality audits as required according to BD Holdings (BDH) Audit Schedule/Program to ensure compliance with the applicable procedures.
- Executes any other tasks and/or projects as assigned by the Quality Snr Manager/Management, Greater Asia.

**Job Requirements**
- Education: Bachelor degree in a Science discipline or other relevant discipline.
- Experience: Minimum 5 years relevant quality assurance and/or regulatory compliance experience in the medical device industry.
- Demonstrated k