Regulatory – Manager

Location: Electronic Co-operative Industrial Estate, Parvati Paytha, Pune

Job Type: Full Time (Work from Office)

About Us: Serigen is an innovation-driven tissue generation products company founded with the vision to become a global leader in biomedical devices. We are seeking a proactive and organized Manager to support directors and the team in ensuring compliance to the regulatory requirements related to the products of Serigen and the implementation of QMS (ISO 13485)

Key Responsibilities:

• Developing the regulatory strategy for various products in India and other global markets
• Preparing and submitting documentation required for regulatory approvals
• Co-ordinating and communicating with regulatory agencies for seeking various regulatory approvals
• Leading and conducting clinical investigations required for various geographical approvals
• Coordinating with R&D, manufacturing & sales teams for data required for
  regulatory submissions
• Implementing, improving and monitoring the Quality Management System
• Conducting internal and external audits for ISO 13485
• Leading/mentoring a team of regulatory assistants
• Managing stakeholder relationships with regulators, clinicians, consultants, auditors, etc.
• Monitoring any changes in regulations/policies as issued by various regulatory bodies from time to time and ensuring compliance

Together, We Create a Safe, Accessible, and Inclusive Space for Everyone Additionally, a regulatory affairs manager may provide strategic advice and guidance to senior management on regulatory issues and opportunities.

Candidate’s Profile:
● Masters’s / Ph.D. degree in Biological Science, Chemistry, Biotechnology
● Proven experience up to 2 years in regulatory domain is highly desirable
● Ability to multitask and prioritize tasks effectively.

If interested, please fill the google form using the link below and send the CV to hr@serigenmed.com .

Apply Here: https://forms.gle/QMHD3nPQ6bTj7hUX9