Halma plc is hiring for the position of Executive – Regulatory Affairs in Bengaluru, Karnataka. The role focuses on Indian medical device regulations, regulatory licensing, compliance support, and coordination with international regulatory teams across Halma companies.
Candidates with a degree in Regulatory Management and 1–3 years of relevant experience, including end-to-end experience with India Medical Device Rules (MDR), can apply for this full-time, on-site position.
Job Details
| Particulars | Details |
|---|---|
| Company | Halma plc |
| Job Title | Executive – Regulatory Affairs |
| Location | Bengaluru, Karnataka, India |
| Qualification | Degree in Regulatory Management |
| Experience | 1–3 years |
| Work Mode | On-site |
| Employment Type | Full-time |
| Application Method | LinkedIn Easy Apply |
Position Overview
The Executive – Regulatory Affairs will support Halma companies in understanding and complying with Indian medical device regulations. The role involves regulatory advisory, licence management, coordination with regulatory authorities, documentation, and support for regulatory processes across multiple operating companies.
Key Responsibilities
- Coordinate with international regulatory teams to understand their business requirements for the Indian market.
- Explain India Medical Device Rules (MDR) requirements and provide regulatory guidance.
- Liaise with the Central Drugs Standard Control Organisation (CDSCO) and regulatory officers to obtain clarifications.
- Engage external India MDR consultants when required.
- Evaluate, recommend, implement, and use technology platforms for managing licences and regulatory workflows.
- Support regulatory compliance while minimising business disruption.
- Participate in regulatory advocacy through Medical Technology Association of India (MTAI) membership.
- Manage regulatory licence applications related to the Petroleum and Explosives Safety Organisation (PESO).
- Coordinate Government e-Marketplace (GeM) portal registration for overseas Halma companies, including document collection, submissions, follow-ups, and online factory audits.
Eligibility and Qualifications
Candidates should meet the following requirements:
- Educational Qualification: Degree in Regulatory Management.
- Experience: 1–3 years of relevant experience.
- India MDR: Core end-to-end experience with Indian Medical Device Rules.
- Regulatory Platforms: Experience using regulatory licence management platforms.
- Additional Exposure: Legal Metrology and labelling, Unique Device Identification (UDI), MRP and pricing, trade margins, customs, and related operational issues.
- Preferred Exposure: European Medical Device Regulation (EU MDR) and US Food and Drug Administration (FDA) requirements.
Required Skills
- Indian Medical Device Rules (India MDR)
- Regulatory Affairs and Licensing
- Regulatory Documentation and Due Diligence
- CDSCO Coordination
- Regulatory Licence Management Platforms
- Legal Metrology and Labelling
- Unique Device Identification (UDI)
- MRP, Pricing, and Trade Margins
- Customs and Regulatory Operations
- GeM Portal Registration
- Stakeholder Communication
- Process Management and Execution
- Regulatory Compliance and Risk Management
