If you are looking to build a career in regulatory affairs within the healthcare and medical devices sector, this opportunity with Siemens Healthcare Private Limited can be a strong step forward. The company is hiring a Regulatory Affairs Professional for its Gurugram location, offering exposure to both Indian and international regulatory environments.
This role is ideal for professionals who want to work closely with medical device regulations and ensure compliance across multiple countries.
Job Overview
Key Details
- Position: Regulatory Affairs Professional
- Company: Siemens Healthcare Private Limited
- Job ID: 498183
- Job Type: Full-time, Permanent
- Work Mode: Office/Site
- Experience Level: Mid-level Professional
- Location: Gurugram, Haryana, India
- Department: Quality Management
Roles & Responsibilities
As a Regulatory Affairs Professional, you will be responsible for handling regulatory compliance for medical devices and IVD products.
Key Responsibilities include:
- Managing pre-market and post-market regulatory activities for medical devices and IVDs
- Ensuring compliance with Medical Device Rules 2017 (India)
- Supporting regulatory submissions for import and manufacturing approvals
- Coordinating with internal teams to maintain regulatory documentation
- Handling regulatory requirements for international markets including:
- Bangladesh
- Sri Lanka
- Nepal
- Bhutan
- Maldives
- Monitoring changes in regulatory guidelines and implementing updates
- Supporting audits and inspections related to regulatory affairs
Required Qualifications
To be eligible for this role, candidates should have:
- Bachelorโs or Masterโs degree in:
- Pharmacy
- Life Sciences
- Biomedical or related field
- Relevant experience in regulatory affairs or quality management
- Knowledge of:
- Medical Device Rules 2017
- IVD regulations
- Strong documentation and communication skills
- Ability to manage multiple regulatory submissions
Salary & Benefits
- Estimated Salary Range: โน6,00,000 โ โน12,00,000 per annum
- Performance-based growth opportunities
- Exposure to global regulatory frameworks
- Work with a reputed healthcare technology company
- Professional development and learning opportunities
How to Apply
Interested candidates can apply directly through the official Siemens careers portal using the Job ID 498183.