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
- 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.
- 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