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Job Id 181102
Title Regulatory Specialist
Job Type Permanent
City Hyderabad
State Telangana
Job Description

• Write business proposals with complete analysis of the requirements, providing regulatory approach.
• To support the Regulatory compliance - gap analysis and remediation of the dossiers.
• To understand and support for the QMS services as per ISO 13485/21 CFR part 820.
• To understand classification of Medical devices as per Medical Device Rules 2017and assist in the identification of potential product technical file and/or clinical report improvements
• To understand EU classification of the product, CE Marking procedure and compilation and review of the MDR/MDD and IVDR/IVDD technical files for EU markets.
• To evaluate the product classification in-line with US-FDA and Global requirements and support the preparation/compilation, review and finalize the regulatory submissions as per regulatory requirements.
• To understand and have knowledge on the implementation of the Risk Management File, Plan and Procedures as per ISO 14971.
• Risk Management Reports writing as per ISO 14971.
• Usability Engineering Reports writing as per ISO 62366.
• Follow Quality System procedures to ensure compliance with 21 CFR 820, ISO 13485, MDD/MDR, AIMD for regulatory compliance in alignment with client objectives.
• Interpret and communicate regulatory changes to ensure the client is aware of opportunities, risks and issues while being responsible for ensuring compliance with the regulations and client’s processes and procedures.

Experience 2-5yrs
Job Category Regulatory Affairs
Posted On 11/14/2018
Expires On 3/14/2019
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