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Pharma professionals with regulatory expertise have a new career opportunity! A leading global healthcare and technology company is hiring for the position of Executive – Regulatory Affairs in Bengaluru. This role is ideal for candidates with 1–3 years of experience in India MDR and medical device regulations.
If you are passionate about compliance, regulatory strategy, and ensuring smooth business operations in India’s fast-evolving healthcare sector, this job could be your perfect fit.
Key Responsibilities
As an Executive – Regulatory Affairs, you will:
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- Conduct regular meetings with international regulatory teams of Halma companies to align with Indian market needs.
- Provide clarity and guidance on India Medical Device Rules (MDR).
- Serve as consultant, advisor, and regulatory guide with a solution-oriented approach.
- Liaise with CDSCO, including travel to Delhi for regulatory meetings.
- Collaborate with external India MDR consultants when necessary.
- Evaluate and implement regulatory technology platforms for license and process management.
- Minimize regulatory risks and ensure compliance continuity.
- Leverage MTAI membership for advocacy and represent Halma’s perspective.
- Manage PESO license applications and required documentation.
- Oversee GEM portal registration for overseas Halma companies, including audits and submissions.
Qualifications & Skills Required
- Degree in Regulatory Management or equivalent.
- Experience: 1–3 years in regulatory affairs, with hands-on knowledge of India MDR.
- Core end-to-end MDR licensing experience.
- Familiarity with regulatory license platforms.
- Exposure to legal metrology, labelling, UDI, MRP/Pricing/Trade Margins, and customs processes.
- Advantageous: Knowledge of European MDR and FDA regulatory frameworks.
- Strong communication, process orientation, and stakeholder management skills.
Why Join?
- Work with a multinational group known for innovation and compliance.
- Opportunity to interact with international teams and regulatory bodies.
- Enhance your expertise in MDR, PESO licensing, and GEM portal processes.
- Competitive salary package in Bengaluru.
- Career growth in global healthcare compliance and regulatory affairs.
How to Apply
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