Job Title: Regulatory
- Manager

Location:
Pune

Job Type
Full time (Work from Office) Medtech Organisation

Key Responsibilities
• Global Strategy Development: Formulate, lead, and execute end-to-end regulatory strategy for creative tissue regeneration products across Domestic (India) and Key International Markets (US FDA, EU MDR, APAC, etc.).
• Dossier & Submissions Management: Prepare, review, and submit regulatory documentation required for global pre-market and post-market approvals.
• Manage regulatory & Stakeholder Relations: Direct communications and build strong working relationships with regulatory agencies, auditors, clinical trial sites, external consultants, and key stakeholders.
• QMS Compliance:



Oversee internal and external ISO 13485 audits and mentor a team of regulatory specialists.
• Intelligence & Advisory: Monitor global regulatory policy updates and provide strategic regulatory guidance to executive leadership. Candidate’s Profile: Education Master’s or Ph.
D. in Biological Sciences, Chemistry, Biotechnology, Biomedical Engineering Work Experience
• Total

Experience:
Minimum 10 years of dedicated experience in Regulatory Affairs and Quality Systems within the Medical Device or Biomaterials/Biomedical industry, specifically, in the areas listed below
• For PhD candidates, 5–6 years of relevant experience will be considered.

📌 Regulatory Manager on Medical devices (Pune)
🏢 Medtech
📍 Pune