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 innovative 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 robust 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