Senior RAQA Specialist

The Role:

In this role, you will ensure full compliance with any applicable regulatory and quality requirements of all regulatory bodies prior to the import and supply of the medical devices that are under Envista product portfolio in South Korea market. You will also act as Regulatory Business Partner to Commercial Team and support Go to Market (GTM) and Revenue Plan for South Korea.

Scope:

Region:            South Korea

Business:   Envista product portfolio with identified product lines for South Korea

Key Responsibility

Product Registration/Licensing Management

• Provide innovative regulatory strategies for new product introductions and product changes and assist in maintaining regulatory compliance in South Korea.

• Identify gaps that that could affect execution and convert global or regional regulatory strategies into practical local strategies.

• Plan product registrations including change notification and renewal, develop registration dossiers for submission, and monitor the progress, status, and timeline.

• Work closely with Global, OpCo and regional APAC RA teams, engage with various departments, and liaise with business partners and dealers to achieve regulatory goals that support business objectives.

• Obtain the regulatory approval for new registration and variations of medical devices in South Korea by ensuring quality and timely submission to regulatory authorities, thereby enhancing business expansion through faster time-to-market achievement.

• Ensure that KGMP certificates and product licenses are renewed promptly and keep the registration database up to date.

• Be proactive in identifying and addressing possible delays in regulatory submission and approval by consistently monitoring progress. Implement temporary or long-term solutions as needed, while maintaining open and prompt communication with your reporting manager and other stakeholders to collaborate on risk mitigation strategies at the earliest opportunity.

• Ensure compliance by adhering to the QA requirements.

• Adhere to all applicable local regulations when carrying out the designated duties and obligations as outlined in the local regulations, guidelines, and similar documents.

• Keep abreast of the regulatory changes and trends and provide assessments of the impact of new and changing regulations on company’s areas of interests to the management. Ensure that RA Teams (both Global and APAC) and stakeholders are promptly briefed about emerging regulatory issues and create strategies to mitigate regulatory risks or leverage potential advantages.

RA/QA Operational Matters

• Manage post-market surveillance activities such as customer complaints, adverse events, and field safety corrective actions (FSCA) including product recalls. Work closely with Global and APAC RA/QA team to ensure prompt reporting to the relevant Authorities until FSCA closure.

• Develop and maintain a Quality Management System customized to comply with the specific regulations of South Korea to secure the required Establishment Operational Licensing, ensuring seamless operation of the business.

• Develop, implement, and maintain the required standard operating procedures (SOP), and provide necessary trainings on the regulatory and quality topics to relevant stakeholders.

• Manage all relevant regulatory assessments and inspections.

• Exercise independent discretion in determining the strategic course of action for the business, which has a direct influence on the operational outcomes of the local markets.

• Review and validate marketing and labeling materials.

• Oversee the screening and regular evaluation of RA/QA partners through the utilization of the Channel Partner Toolkit (CPTK), ensuring that our RA/QA partners uphold the same integrity standards mandated by Envista.

Build Continuous Awareness within Organization on applicable RA Framework

• Be analytical and innovative to drive the execution of continuous improvement in RA/QA operational processes to improve the effectiveness and efficiency.

• Represent strongly local Affiliate Regulatory Affairs’ interest and be an outstanding business partner with Global and APAC RA/QA Teams and regional/local Sales and Marketing teams.

• Establish and build on relationships with key contacts within the organization to support the country, and ensure the strong relationship with the industry associations, regulatory agencies, and external stakeholders.