Regulatory Affairs Professional

Siemens Healthineers AG; Gurugram District; On-site; INR 3,500,000 - 4,500,000; Full time

Job summary

Siemens Healthineers AG in India seeks a Regulatory Affairs professional to ensure pre-market and post-market compliance for Medical devices and IVDs under MDR 2017 and CDSCO regulations. You will interact with local business teams and global RA groups to file applications and address queries.

Responsibilities include post-market surveillance, coordinating Field Safety Corrective Actions, and maintaining document trackers while supporting zone partners in nearby regions and keeping up with

Qualifications

• Experience in pre-market and post-market regulatory work under MDR 2017 and CDSCO.
• Knowledge of Medical Device and IVD device regulations in EU, USA, Bangladesh, Sri Lanka, Bhutan.
• Strong communication and interpersonal skills.

Responsibilities

• Interact with local business teams and global RA teams to prepare regulatory submissions.
• Follow up with CDSCO for licenses/approvals for medical devices and IVDs.
• Perform post-market surveillance reporting for registered devices.
• Coordinate with service & logistics for Field Safety Corrective Actions.
• Maintain documentation and trackers; support quality system audits.

Skills

Communication skills

Interpersonal skills

Education

BPharm/ BSc/ BTech

Job description

Job Requirements

Job Duties & Responsibilities: This position is primarily to support for ensuring pre-market & post-market regulatory compliances for import/ manufacture of Medical devices and IVD devices under Medical Device Rule 2017 and other applicable regulatory requirements in India. This position will also support in fulfilling the regulatory requirements for these devices in zone countries of Bangladesh, Sri Lanka, Nepal, Bhutan & Maldives. Job Description: Responsible to interact with local business teams and global RA teams & make applications, clarify to queries, follow up with CDSCO for obtaining regulatory licenses/ approvals for Medical devices and IVD devices as required. Perform post market surveillance compliance & reporting requirements for the registered devices. Coordinate with service & logistics teams for the Field Safety Corrective Actions implemention. To evaluate, apply & obtain approvals for the Product Change Notifications for registered devices. Support business partners in zone countries like Bangladesh, Sri Lanka, Nepal, Maldives & Bhutan to comply regulatory requirements related to Medical devices and IVD devices as required. Maintain documentation related to all above topics including progress & record trackers. Support Quality system audits of service agencies and dealers/ distributors. Keep abreast of new regulations and updates/ changes to existing regulations & requirements for the devices

Job Requirements

Job Duties & Responsibilities: This position is primarily to support for ensuring pre-market & post-market regulatory compliances for import/ manufacture of Medical devices and IVD devices under Medical Device Rule 2017 and other applicable regulatory requirements in India. This position will also support in fulfilling the regulatory requirements for these devices in zone countries of Bangladesh, Sri Lanka, Nepal, Bhutan & Maldives. Job Description: Responsible to interact with local business teams and global RA teams & make applications, clarify to queries, follow up with CDSCO for obtaining regulatory licenses/ approvals for Medical devices and IVD devices as required. Perform post market surveillance compliance & reporting requirements for the registered devices. Coordinate with service & logistics teams for the Field Safety Corrective Actions implemention. To evaluate, apply & obtain approvals for the Product Change Notifications for registered devices. Support business partners in zone countries like Bangladesh, Sri Lanka, Nepal, Maldives & Bhutan to comply regulatory requirements related to Medical devices and IVD devices as required. Maintain documentation related to all above topics including progress & record trackers. Support Quality system audits of service agencies and dealers/ distributors. Keep abreast of new regulations and updates/ changes to existing regulations & requirements for the devices

Work Experience

Experience and Qualification: BPharm/ BSc/ BTech with 6-8 years’ experience of pre-market & post market regulatory work on compliance to Medical Device Rules (MDR) 2017, Drugs & Cosmetics Act & Rules governed by Central Drug Standard Control Organization (CDSCO) for IVD medical devices and IVD devices. Should have knowledge about medical device & IVD devices regulations in EU & USA, Bangladesh, Sri Lanka, Bhutan. Good communication & interpersonal skills.