Regulatory Affairs and Quality Professional

Job Description

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

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