POSITION –   LEAD- REGULATORY AFFAIRS

LOCATION  – PARWANOO, HIMACHAL PRADESH/ CHANDIGARH

DIVISION BUSINESS – MANAGER HEAD OF US & EUROPE AND STRATEGIC RELATIONSHIPS

SPAN OF CONTROL  – INDIVIDUAL CONTRIBUTOR

ROLE TYPE –  FULL TIME

TRAVEL REQUIRED <20%

SAALARY Package  – 25LPA

QUALIFICATIONS AND EXPERIENCE REQUIRED

• Graduate in any field, preferably in Biotechnology or life sciences.
• 5-10 years of experience in managing regulatory affairs for a biomedical device company.
• Hands-on experience in creating and filing dossier for USFDA, Notified CE and thorough
understanding of ISO 13485 documentation and implementation.
• Experience in dealing with regulatory bodies and factory-based teams

RESPONSIBILITIES
• Keeping track of the ever-changing legislation in all the Indian and International regions in which the
company wishes to distribute its products. (Primarily US, Europe, India)
• 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.

#regulatoryaffairs #regulations #medicaldevices #testkits

If interested can forward your updated resume on hrd@tasolutions.in and can directly contact us on 9056679449  also can provide our reference to your friends and colleagues.