Team Member

**Division**:
**Department**:
**Sub Department 1**:
**Employment Type**:
**Job Purpose**:
Provide all regulatory requirement to R&D teams as Device Regulatory partner for all Combination Products and Devices to guide on US-FDA / EU-MDR pertaining to device constituent part in combination products & standalone device regulatory requirements for device approval in target countries. Collaborate within Regulatory Affairs team and work with Respi, CDT & Regional regulatory teams on compiling/reviewing dossier sections pertaining to combination products and devices as per requirements/procedures/guidelines within the specified timelines.

**Key Accountabilities (1/6)**:
**Accountability Cluster**:
Provide support R&D teams (Device team and F&D teams) on regulatory requirements for device constituent part in combination products and device regulatory aspects.

**Major Activities / Tasks**:

- Support R&D teams during Design Control activities of device constituent part in combination products through preparing of design input (creation of URS considering all product-specific regulatory requirements), design output documents, risk management, design verification (ensure all aspects of verification requirements as per regulatory expectation is covered for combination product/ devices) and validation plans & reports (Ensure design, documentation and regulatory filing requirements are fully compliant to all Threshold Analysis, Human Factors and usability engineering related guidance and standards)
- Support R&D teams in compilation and perform preparing of technical file/design history file/design dossier documents against regulatory requirements
- Support R&D teams in validating necessary documentation requirements during design transfer to device manufacturing facility, as per regulatory requirements
- Work with R&D and cross-functional teams to evaluate proposed device design changes for regulatory impact and to suggest developing necessary documentation
- Intimate/escalate any delays in device design control activities to manager on monthly basis

**Key Accountabilities (2/6)**:
**Accountability Cluster**:
Support Respi, CDT & Regional Regulatory teams

**Major Activities / Tasks**:

- _Support Respi, CDT team in preparing dossier sections for combination products involving device constituent part and devices by providing relevant inputs _as per requirements/procedures/guidelines and preparinging relevant sections within the specified timelines_

**Key Accountabilities (3/6)**:
**Accountability Cluster**:
Act as Point of Contact for Device Regulatory aspects within the Regulatory team

**Major Activities / Tasks**:

- Maintenance of global registration/approval database and archive licenses for stand-alone devices worldwide
- Keep abreast on current device and combination product related global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
- Upkeep of appropriate regulatory documentation related to devices and combination products _involving device constituent part _are created and properly maintained (e.g. Project Design & Development Plan, Risk Management, design input, design output, design verification, design validation, design transfer).
- Provide device regulatory support to currently marketed devices.
- Maintenance of Device Regulatory files to support compliance with regulatory requirements.

**Key Accountabilities (4/6)**:
**Accountability Cluster**:
Support cross-functional teams

**Major Activities / Tasks**:

- Provide on-going support to project teams for combination product & device regulatory issues and questions
- Be a part of project team across the entire device design & development cycle.Provide inputs and adhere to compliance on changes in the regulatory intelligence / competitor intelligence to the Regulatory Intelligence team

**Key Accountabilities (5/6)**:
**Accountability Cluster**:
Support CQA & Manufacturing teams during inspection of combination products or devices

**Major Activities / Tasks**:
Ensure availability of all design development documents are available at the manufacturing unit during inspections & provide support in answering any queries related to device development

**Key Accountabilities (6/6)**:
**Major Challenges**:

- Co-ordination with various R&D teams & other internal stakeholders and making sure all device constituent part related regulatory documentation is generated as per regulatory requirement in a timely manner & escalation, if required.
- Regular communication/discussions with various RA teams w.r.t challenges faced by them in complying to the regulatory documentation requirements as per combination product regulation/guideline or device regulation/guidelines, resolve & facilitate/support in completion of tasks.

**Key Interactions (1/2)**:
Internal:

- Various R&D teams ��� regularly, weekly/need basis, follow up for required data for ensuring regulatory req