• Keeping track of the ever-changing legislation in all the Indian and International regions in which the company wishes to distribute its products.
• Advising on legal and scientific restraints and requirements
• Collecting, collating, and evaluating scientific data
• Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned
• Giving strategic and technical advice at the highest level in the company, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole
• Conscious tracking of any gaps and errors in documentation and continuous updating as necessary.
• Aligning the efforts of the plant team as per regulatory norms.
• Regular audits and creating a structured review mechanism
• Graduate/Post Graduate in Science, preferably in Biotechnology / Chemistry or life sciences. • 18 – 20 years of experience in managing regulatory affairs for a medical device company. • Hands-on experience in creating and filing dossier for USFDA, Notified Bodies CE and thorough understanding of ISO 13485 documentation and implementation. • Experience in dealing with regulatory bodies and factory-based teams.
Ascent Human Solutions (P) Limited is a 23 years old leading HR company in India offering end-to-end Human Resources Management Services and have been serving its clients that include MNCs and Big Indian Corporate.
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