Regulatory Affairs Professional

  Regulatory Affairs

Job title: Regulatory Affairs Professional

Company: Siemens

Job description: Role: Regulatory Affairs Professional

External Title: Deputy General Manager

Position Headline

Lead and spearhead the Regulatory/ legal compliance requirements of Pre-Conception and Pre-Natal Diagnostic techniques and ensure compliance across the organization.

Job Duties and Responsibilities

This position is primarily responsible to ensure pre-market and post-market legal and regulatory compliance requirements of Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, and The Pre-Conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, as well as the state PCPNDT rules and guidelines (at PAN India level) as applicable to all medical Imaging equipment from Siemens Healthcare Private Ltd., (SHPL) in India.

Job Description

  • Responsible for making applications for registration of SHPL as importer/ supplier/ distributor/ manufacturer 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 PCPNDT 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 to users.
  • Liaising and coordinate with PCPNDT authorities (Central, States and Districts) for clarifications on compliance requirements from all levels of the organizations.
  • Actively coordinating through Industry Associations on any draft requirements from Central/ State/ District PCPNDT Authorities or any contentious topics with respect to PCPNDT and drive for timely representations and seek resolution from respective authorities.
  • Providing expert assessment and coordinating for timely responses with respect to any notices or queries from various PCPNDT authorities 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 to ensure requirements of PNDT is met across and drive actions in case of any gaps.

Business Specifications:

  • Ensuring and complying with all applicable PCPNDT requirement across Siemens Healthcare Private Ltd., as importer/ supplier/ distributor/ manufacturer
  • Ensure there is no enforcement and no business disruptions due to PCPNDT non-compliance.

Dimension of Function:

  • Ensuring of compliance to PCPNDT requirements in the entire organization, keeping abreast of new developments at Central/ State/ District authorities.
  • Registration/ renewal/ periodic reporting and responding any queries/ notices on timely manner.
  • Taking timely measures/ remediation to ensure compliance, ensuring zero enforcement with respect to PC-PNDR regulations and legal requirements.

Management of Stakeholders (Internal/ External)

  • Business Teams, Project Management, Customer Service, Legal, Compliance team
  • Central/ State PC-PNDT authorities, District Appropriate Authorities, Industry associations, Business Partners/ Distributors, etc.,

Experience and Qualification

  • Regulatory/Quality professional with Degree in Science from a recognized University/ Institution having 6 to 8 years of experience in pre-market and post-market activities pertaining to compliance of Medical Imaging Equipment such as Ultrasound, CT, MRIC machines
  • Legal Professionals (LLB) having experience in PCPNDT compliance 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

Expected salary:

Location: Bangalore, Karnataka

Job date: Mon, 02 May 2022 22:30:03 GMT

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