Head/Senior Manager - Quality Assurance & Regulatory Affairs - Diabetes Care

Head/ Sr. Manager- QA & RA (Diabetes Care)

Specific Responsibilities :

AQH & LSO Responsibilities

- Safety Board /Recalls and Customer Notifications

- Serves as primary Affiliate contact for Safety Board matters.

- Responsible for prompt execution of, and communications related to, Safety Board decisions, pursuant to Safety Board instructions.

- Serves as primary contact for local regulatory authorities related to complaints, recalls and/or corrective field actions. Promptly informs relevant Safety Board Chair and/or Business Area (BA)/Business Unit (BU)/Global Platforms and Support (GPS) of any such contact.

Complaints :

- Responsible for development and implementation of local processes to capture, document, and manage inquiries, complaints, and logistics claims in a timely manner.

- Provides training on complaint handling to employees as required to comply with applicable regulations and Diagnostics processes.

- Enforces correct and accurate use of the IT system(s) used for complaint case management.

- Ensures that any third-parties involved in the complaint handling process are governed by a suitable written agreement.

Notifications :

- Notifies the Head, Global Quality and Regulatory, and the Head of Global Quality and Compliance of any material regulatory inspections and outcomes thereof (e.g. FDA or other regulatory authority).

- Notifies the applicable Safety Board Chair upon receipt of communications from regulatory authorities related to a product quality or safety issue.

Supply Chain :

- Monitors supply chain quality, as applicable, and ensure that product specifications are maintained throughout the supply chain.

Training and Communication :

- Responsible for Affiliate adoption, training, and implementation of local processes in accordance to the applicable Divisional Standards.

- Ensures appropriate Quality Management- related processes are in place, communicated, and that relevant employees are adequately trained.

- Serves as local contact for GQC and as the Affiliate conduit for sharing of information related to Quality Management.

Monitoring of Quality & Regulatory Metrics :

- Monitors and assesses Key Performance Indicators (KPIs) as defined by Global Q&R, and ensures that local Management Review occurs.

Local Regulatory Officer Responsibilities :

Submissions :

- Acting as applicant and owner of the submissions process.

- Acting as primary contact for the local Regulatory Authority regarding registration of products distributed by Diagnostics in the country.

- Informing the local organization (i.e. Logistics and Marketing), on registration status of Diagnostics products to ensure legal import and distribution.

Regulatory Intelligence :

- Provides timely feedback to the Global Regulatory Submissions Affiliate Coordinator and the BA/BU/GPS Diabetes Care function on changes to local regulatory requirements.

- Cooperates with Global Regulatory Submissions and local importers associations to influence registration requirements.

- Provides information and interpretation regarding regulatory requirements to the Global Regulatory Submissions Affiliate Coordinator and BA/BU Diabetes Care function needed to develop Regulatory Strategy, Clearance Plans and Regulatory opinions.

Local Regulatory Processes :

- Provides regulatory support for local Quality Control (including advice on importation of materials).

- Provides Regulatory training to employees as required to meet compliance with local laws and regulations.

- Specifies requirements for local labeling of Diagnostics products.

- Cooperates with quality and logistic functions for certification of Good Importation and Good Distribution Practices.

- Ensures compliance with Local promotional requirements, and Regulatory Divisional Standards.

Qualifications & Experience :

- About 12-15 years of relevant working experience.

- Academic education in an appropriate scientific/medical discipline and/or experience within the medical device or Pharmaceutical industry.

- Detailed knowledge of local regulatory requirements for medical devices, particularly concerning local and global complaint management and reporting.

- Understanding of global regulatory requirements for medical devices and general principles of Quality Management.

- Expert knowledge and understanding of applicable Divisional Q-Standards.

- Expert knowledge and understanding of the Potentially Critical Complaint (PCC) process.

- Well-developed sense of urgency and risk assessment skills.

- Able to develop and maintain links across multiple levels within the local and global RD organization and with local regulatory authority.

- Direct reporting or direct access to General Manager/Local Head of Diabetes Care.

- Preferably ISO 13485 lead auditor or similar experience

- Training in and experience of ISO9001:2008, ISO13485:2003, MDD. Training in QSR is an advantage

- Should have experience in managing team member.