Regulatory Compliance Specialist
2 weeks ago
Job Title: Regulatory Compliance Specialist
Job Summary:
We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Siemens Healthcare Private Limited. The successful candidate will be responsible for ensuring pre-market and post-market regulatory compliance for import/manufacture of diagnostics/in vitro devices and medical devices under the Medical Device Rule 2017 and other applicable requirements in India.
Key Responsibilities:
- Interact with local marketing, global RA teams, and make applications, clarify to queries, and follow up with CDSCO for licenses of IVD devices and medical devices regulated under Medical Device Rules 2017.
- Obtain new wholesale licenses of IVD devices and medical devices from state FDA, renew/amend existing licenses as required.
- Perform post-market surveillance compliance and reporting for the registered devices.
- Evaluate, apply, and get product change notifications approved for registered devices.
- Coordinate with CS and logistics teams to get field safety corrective actions implemented for devices.
- Support business partners in zone countries like Bangladesh, Sri Lanka, Nepal, Maldives, and Bhutan to fulfill regulatory requirements related to IVD devices and medical devices.
- Perform quality system audits of suppliers, service agencies, and business partners.
- Maintain documentation related to all the above topics, including progress and record trackers.
- Keep abreast of updates/changes to applicable regulations and requirements for the devices and represent SHPL at industry forums on regulatory topics.
Qualification and Experience:
BPharm/M Pharm/BSC/MSc with 6-8 years' experience of pre-market and post-market regulatory work on compliance to Medical Device Rules (MDR) 2017, Drugs and Cosmetics Act & Rules governed by Central Drug Standard Control Organization (CDSCO) and state FDA for IVD and medical devices. Should have knowledge about IVD devices and medical device regulations in EU, USA, Bangladesh, Sri Lanka. Good communication and interpersonal skills.
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