• 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.
Ascent Human Solutions Pvt. Limited
Ascent Human Solutions Pvt. Limited
Ascent Human Solutions Pvt. Limited
Ascent Human Solutions Pvt. Limited
Ascent Human Solutions Pvt. Limited
