Regulatory Affairs Specialist

Job Title : Regulatory Affairs Specialist

Location : Bangalore

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Responsibilities

• This position supports the regulatory lead of LSLPG, GSG and BPG India business.

• Compilation and review of registration application, online (Sugam portal)/hard copy submissions to MD/IVD sections of CDSCO (Central Drug Standard Control Organization), New Delhi.

• Prepare and submit regulatory submissions to the Authorities in South Asia and lead type test/clinical studies where needed in support of the product filings.

• Getting the product change notifications implemented for LSLPG, GSG and BPG products.

• Preparation, verification & maintenance of various documents like device master file, site master file, technical file as per requirements of various countries regulatory body like CDSCO, CE-MDR, USFDA etc.

• Following up with CS team to get the field safety corrective actions implemented for LSLPG, GSG and BPG products.

• Support Post Market Surveillance of regulated products in India. Work with cross functional teams, operations, and customers to resolve and implement corrective and preventive actions resulting from technical complaints.

• Applying Duel Use NOC for India customs clearance.

• Liaison with Authorities /officials to ensure timely approvals & availability of valid licenses.

• Regulatory liasioning and follow up with CDSCO office for status of applications and for any new update regarding our registered products.

• Teleconferences with global affiliates to process and clarifications on documents for ease of applications to be submitted as CDSCO.

• Support LSG Indian Plant QMS/GMP and implement regulatory affairs activities.

• Participate in company regulatory/quality audits and assist, as needed.

• Other tasks assigned by line manager.

Requirement

• Bachelor’s degree or higher degree in Engineering, Pharmacy, Sciences or Medicine.

• Over 4-8 years relevant experience of premarket & post market work on compliance to Medical Device Rules (MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) for IVD & other medical devices.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status

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