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Centrak
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Executive - Regulatory Affairs

Executive - Regulatory Affairs

Centrak

1 - 3 years

3 - 5 Lacs

bengaluru

Posted:Just now| Platform:

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Skills Required

trade due diligence medical devices usage executive regulatory affairs legal agile metrology licensing operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Its fun to work in a company where people truly BELIEVE in what they are doing!
Were committed to bringing passion and customer focus to the business.

Responsibilities:

Have regular meetings with international Regulatory Teams of Halma Companies to understand their evolving business needs wrt Indian market.
Assist them in understanding the India MDR with clarity.
Serve as a consultant, advisor and guide to the International Regulatory team with a solution orientation.
Reach out to CDSCO or travel to Delhi for mtg with regulatory officers to seek clarification.
Tap into External India MDR Consultant as and when required.
Evaluate, Recommend, Implement and Use technology and platforms to manage licences and process flows for multiple Operating Companies within the Group.
Minimise risk to business disruption from regulation.
Agile and responsive to changing regulatory environment and evolving business needs.
Use MTAI membership effectively for advocacy as well as position Halma s point of view whenever required.
In addition, there are regulatory license applications for PESO to be also managed with a list of documents.
GEM portal registration for Halma companies based abroad including providing checklist, outlining process, following up for documents, submission of the same, and facilitating online video audits of the factories.

Critical Success factors:

Executional Rigor, Due diligence wrt to Documentation, and Process Oriented for day-to-day MDR Licensing requirement.
Understands varying needs across diverse stakeholders especially different types of medical devices.
Transparent and effective communicator with all stakeholders, and commercially savvy when recommending solutions.
Deep and Clear understanding of evolving India MDR.

Qualifications:

Degree in Regulatory Management.

Experience:

Minimum 1 to 3 years of relevant experience.
Core end-to-end experience in India MDR.
Experience in Regulatory License platforms.
Exposure to Legal Metrology & Labelling, UDI, MRP/Pricing/Trade Margins, Customs and other related operational issues.
Exposure to European MDR and FDA would be advantageous.

If you like wild growth and working with happy, enthusiastic over-achievers, youll enjoy your career with us!

Not the right fit Let us know youre interested in a future opportunity by clicking Introduce Yourself in the top-right corner of the page or create an account to set up email alerts as new job postings become available that meet your interest!

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Centrak

Healthcare Technology/RTLS

Glen Allen

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Executive - Regulatory Affairs