Internal Title - Regulatory Affairs Professional
External Title - Manager - Quality Management
Regulatory Affairs (60%)
- The position is to support for ensuring pre-market & post-market regulatory compliances for import/ manufacture of Diagnostics/In vitro devices (IVD) and medical devices under Medical Device Rule 2017 and other applicable requirements in India and neighbouring countries.
- To perform PMS surveillance compliance & reporting for the registered medical devices and evaluate, apply & get the Notifications approved for registered medical devices.
- To develop and record documentation related to MDR 2017 and keep updated on latest regulatory guidelines.
- Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.
- Identifies, analyzes and implements India specific requirements necessary for product related submissions as per MDR 2017 or relevant guidelines.
- Plans and prepares product related submissions with Siemens internal (e.g. Regional Units) or external organizations (export related requirements) according to regulatory requirements.
- Performs regulatory projects or acts as a member of the project steering group related to LD and POC lines.
- Submits required documentation/information to local authorities or Siemens internal stake holders. (PLM, R&D, Marketing, Procurement, Logistics and QA/QC)
- Coordinate with TTP (Technical Transfer Professional) for new products or any updates for RA requirements.
- Initiates and escalates necessary activities if deviations are identified.
- Ensures creation of adequate documentation for audits/inspections.
- Performs training within the organization in country specific regulatory requirements, if applicable. Performs review of promotional material for regulatory compliance according to country specific requirements.
- Visit CDSCO, State FDA, Local FDA and other regulatory authorities as and when required.
- May represent the company in industry associations (Lobbying), if applicable.
- Train subordinates on RA roles.
Quality Assurance (40%)
- Creates measure-/testing-records and makes them available for further analyses.
- Creates first sample qualification reports for development and component engineering and prepares necessary prequalification.
- Supports in setting up new test equipment and measurement tools.
- Supports the maintenance and calibration of the systems and tools in his responsibility.
- Provides and ensures the testing of material and products in the assigned unit according to inspection plans and internal guidelines.
- Initiate escalations in case of failures to the cross functional teams.
- Supports innovative digital solutions to improve quality, work on (Corrective and Preventive Action) CAPA, (Root Cause Analysis) RCA and represent MR as and when required.
- Management Representative for ISO and EHS documents at Vadodara Works.
- Train subordinates on QA roles.
Qualification: Graduate or Postgraduate (in Science, Biotechnology, Pharmacy discipline) with minimum 5 to 7 years’ experience in relevant field.
Competencies: Basic IT knowledge, Basic knowledge of local manufactured products, Documents and Data control.
Knowledge preferred: MDR 2017, ISO 9001, 13485, CE, WHO, US FDA certification and audit.
Organization: Siemens Healthineers
Company: Siemens Healthcare Private Limited
Experience Level: Experienced Professional
Job Type: Full-time