Job Description

Position Summary:
Principal Responsibilities:
Compile and review regulatory submissions for timely registration of new products & on-time renewal of registered
products.

• Develop timelines, coordinate receipt of technical information from global RA and independently execute new product

registrations, change reporting and PAC submissions.

• Review technical documents before submission to external party and/or Health authority to ensure the documents

meet and/or fulfil the country requirement/request. Ensure the documents are legalized and/or notarized where
required.

• Monitor and update registration activities and/or status to all relevant stakeholders on a regular basis. Ensure the

required actions and responses are in place in a timely manner .

• Demonstrate strong understanding of MDR 2017 and associated regulations (LMR, DPCO, Drugs and Magic remedies

Act etc.) in handling medium to complex from Central/ State Licensing Authority/NPPA.

• Timely assessment of incoming changes to global and keep business aligned on impact, if any.

• Oversee India supplementary labeling compliance along-with QA.

• Take lead in project planning, budget review and support in managing RAQA KPI metrics.

• Lead cross-functional discussions with Supply chain planning and L&D operations team to maintain uninterrupted

business continuity.

• Mentoring new team member/associates and lending support in acquiring know-how required to work under minimal

guidance.

• Provide timely intel to reporting manager in sending out key communication, internal document modification to ensure

minimal/no impact to business .

• Monitor changing/new requirements and prepare policies, guidelines, training for employee, to ensure awareness and

timely implementation of same.

• Provide support to Institution business team on tender related requests.

Education:

• The ideal candidate would have a diploma/degree in a scientific discipline such as Biology, Microbiology, Pharmacy,

pharmacology, Biotechnology, engineering, or medical technology.

• Minimum 5 years of experience in Medical devices regulatory affairs and 7-8 years of working experience in a Medical

devices/Pharmaceutical company.

• Good working knowledge of MS-EXCEL and PowerPoint will be preferred.

BEHAVIOUS / VALUES

• Team player having an analytical and problem-solving mindset.

• Highly motivated, willing to learn and having an open mindset.

• Must be approachable and have a positive mindset

• Flexible and adaptable to changing environment and needs

• Must be a patient listener, and have a rational mindset towards solving problems.

• Demonstrate strong integrity in dealing with different external stakeholders