26 Job openings found

Job Overview: The Manager – Global Statutory Compliance will be responsible for ensuring the company's dental implants and medical devices adhere to international regulatory standards, including ISO 13085, FDA, and other country-specific statutory requirements. This role will involve overseeing the creation and management of Design History Files (DHF), ensuring proper document ...

Quality Engineer Standards and Regulations Good knowledge of the relevant Standards/Regulations for medical device manufacturers (ISO 13485, ISO 14971 , MDD, MDR, 510(k) etc.) Ensuring compliance of products as per MI PLM and SHPL QMS requirements Co-ordination with Quality Assurance Manager on various SHPL QMS related activities Conducting/participating in Internal Audits and ...

Quality Engineer Standards and Regulations Good knowledge of the relevant Standards/Regulations for medical device manufacturers (ISO 13485, ISO 14971, MDD, MDR, 510(k) etc.) Ensuring compliance of products as per MI PLM and SHPL QMS requirements Co-ordination with Quality Assurance Manager on various SHPL QMS related activities Conducting/participating in Internal Audits and External ...

Job Profile for QA/RA :  1-2 Years of Experience ? Experience to prepare and review the documentation required for the ISO 9001:2015,EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745,IMDR 2017.? Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s,Change Control, Deviation, CAPA, Incident, and Customer ...

Job Profile for QA/RA :  2 -3 Years of Experience ? Experience to prepare and review the documentation required for the ISO 9001:2015,EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745,IMDR 2017.? Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s,Change Control, Deviation, CAPA, Incident, and ...

Experience to prepare and review the documentation required for the ISO 9001:2015, EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745, IMDR 2017. Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s, Change Control, Deviation, CAPA, Incident, and Customer complaint, Management Review Meeting, pdate Harmonized Standards, ...

Position:         Sr. Executive - RA Location:        Daman Experience:     7 to 8 Years Industries:      Pharma   Responsibilities: Maintaining compliance with Dossiers, ISO 13485, WHO/GMP requirements. Preparing technical and Drug master files Preparing and compiling documents for registration to various countries. Reviewing and updating of documents w.r.t various regulatory requirements Reviewing and updating of ...

Work with global R&D teams to develop software for new and existing medical device products. • Software design and development of embedded real-time systems, including the development of Software Unit Test & Integration plans and protocols. • Participates in reviews, code inspections and will support the development of documentation ...

Develop and implement inclusive recruitment strategies for both fresh graduates and experienced hires Facilitate a welcoming and comprehensive onboarding experience for new hires, aligning with HR standard operating procedures Identify training needs, lead and monitor training plan through collaboration with managers and employees Establish fair and transparent appraisal systems, assisting managers in providing ...

JD For QARA                                                Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking).  Ensure that products meet all regulatory requirements and maintain relevant documentation. Quality Assurance:  Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. Collaborate with ...