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Regulatory Affairs Professional

Job Description

Siemens Healthineers is looking for a Regulatory Affairs Professional for its medical imaging portfolio.

Role/Internal Title: Regulatory Affairs Professional

Business Title : Deputy General Manager

Role Summary

  • Lead and spearhead the Regulatory compliance requirements of Pre-Conception and Pre-Natal Diagnostic techniques and ensure compliance across Siemens Healthcare Private Ltd., as importer/ supplier/ distributor/ manufacturer/ technicians/ refurbisher.
  • To ensure there is no enforcement and no business disruptions due to non-compliance on applicable regulations from PCPNDT.
  • To support the compliance to requirements from BIS/WPC/TEC as applicable to Medical Device/ IVD device and its components in Zone India to ensure there is no enforcement and no business disruptions.

Responsibilities

  • Responsible for making applications for registration of SHPL as importer/ supplier/ distributor/ manufacturer/ technicians/ refurbisher with Central, State and District PCPNDT authorities, clarifying to queries, following-up with authorities for registration certificate. Maintaining SHPL registration certificates and renewing them as required on timely manner.
  • Ensuring quarterly/monthly reporting obligations to the PC-PNDT authorities as required and maintaining records of such reports.
  • Advising and supporting Sales/ Project Management/ Customer service on strategic and operational topics related to compliance with PCPNDT requirements as applicable for uninterrupted supply of medical Imaging devices (like Ultrasound, X-Ray devices, CT, MR, etc.,) to users.
  • Liaising and coordinate with the PCPNDT authorities (Central, States and Districts) for clarifications on compliance requirements from all levels of the organizations.
  • Actively coordinating through Industry Associations on any advocacy activities with Central/ State/ District Authorities or any contentious topics with respect to all applicable Medical Device regulations along with PCPNDT and drive to seek resolution from respective authorities.
  • Providing expert assessment and coordinating for timely responses with respect to any notices or queries from various authorities, including PCPNDT across India.
  • Keeping abreast of updates/ changes to PCPNDT rules and requirements – Central as well as with States and Districts. Perform assessment of applicability and impact to SHPL, liaise with respective business teams and ensuring compliance.
  • Ensuring the PCPNDT compliance requirement of SHPL’s Business Partners/Distributors with respective authorities by driving the requirement through respective business teams.
  • Conduct periodic compliance audit of SHPL processes (across Zone India including Business Partners/ Distributors) to ensure requirements of all applicable regulations and PC-PNDT is met across and drive actions in case of any gaps.
  • Support the global & local BA/ BLs for the assessment and the applicable regulatory registration and compliance of medical devices (like Ultrasound, X-Ray devices, CT, MR, PET, etc.,), in vitro diagnostic devices and their respective components/ spare parts for BIS/WPC/TEC, in India Zone.

Stakeholders (Internal/ External)

  • Siemens Healthineers - global Business Areas/Business Lines, Business Teams, Project Management, Customer Service, Legal, Compliance team
  • Central/ State PC-PNDT authorities, District Appropriate Authorities, CDSCO, BIS, MeitY, WPC, TEC, Industry associations, Business Partners/ Distributors, etc.,

Experience and Qualification

  • Graduate or Postgraduate in Engineering or Master’s degree in Science from a recognized University/ Institution with 6 to 8 years of experience in pre-market and post-market Regulatory activities pertaining to compliance of Medical Imaging Equipment.
  • Legal professionals can also apply.
  • Excellent communication & presentation skills, analytical and interpersonal abilities

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Mid-level Professional

Job Type: Full-time

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