Executive - Regulatory Affairs

Halma plc; Bengaluru; On-site; INR 700,000 - 900,000; Full time

Job summary

Halma India seeks a Regulatory Affairs professional to manage India MDR licensing and related regulatory licenses for Halma's Indian operations.

You will collaborate with international teams, navigate CDSCO interactions, and ensure compliant documentation and processes across our Indian footprint. This role demands strong regulatory knowledge and proactive stakeholder communication.

Qualifications

• Degree in Regulatory Management.
• 1–3 years of relevant experience in India MDR.
• Experience in Regulatory License platforms.
• Exposure to Legal Metrology & Labelling, UDI, MRP/Pricing/Trade Margins, Customs and related operational issues.
• Exposure to European MDR and FDA would be advantageous.

Responsibilities

• Coordinate with international Regulatory Teams of Halma Companies to understand evolving Indian market needs.
• Assist in understanding the India MDR with clarity.
• Serve as a consultant to the International Regulatory team with a solution orientation.
• Engage with CDSCO or travel to Delhi for meetings with regulatory officers.
• Manage PESO license applications and GEM portal registrations for Halma entities.

Education

Degree in Regulatory Management

Job description

Halma is a global group of life-saving technologies companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.

Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of science and technology.

Halma India fulfils the potential of the region by harnessing the diverse talents, expertise, infrastructure, and operational resources. At Halma India, We have a team of over 280 professionals representing commercial, digital, business support group and support functions across our seven offices in India, two in Bengaluru and one each in Delhi NCR, Mumbai, Thanjavur, Vadodara, and Ahmedabad.

Responsibilities:

• Have regular meetings with international Regulatory Teams of Halma Companies to understand their evolving business needs wrt Indian market.
• Assist them in understanding the India MDR with clarity.
• Serve as a consultant, advisor and guide to the International Regulatory team with a solution orientation.
• Reach out to CDSCO or travel to Delhi for mtg with regulatory officers to seek clarification.
• Tap into External India MDR Consultant as and when required.
• Evaluate, Recommend, Implement and Use technology and platforms to manage licences and process flows for multiple Operating Companies within the Group.
• Minimise risk to business disruption from regulation.
• Agile and responsive to changing regulatory environment and evolving business needs.
• Use MTAI membership effectively for advocacy as well as position Halma's point of view whenever required.
• In addition, there are regulatory license applications for PESO to be also managed with a list of documents.
• GEM portal registration for Halma companies based abroad including providing checklist, outlining process, following up for documents, submission of the same, and facilitating online video audits of the factories.

Critical Success factors:

• Executional Rigor, Due diligence wrt to Documentation, and Process Oriented for day-to-day MDR Licensing requirement.
• Understands varying needs across diverse stakeholders - especially different types of medical devices.
• Transparent and effective communicator with all stakeholders, and commercially savvy when recommending solutions.
• Deep and Clear understanding of evolving India MDR.

Qualifications:

• Degree in Regulatory Management.

Experience:

• Minimum 1 to 3 years of relevant experience.
• Core end-to-end experience in India MDR.
• Experience in Regulatory License platforms.
• Exposure to Legal Metrology & Labelling, UDI, MRP/Pricing/Trade Margins, Customs and other related operational issues.
• Exposure to European MDR and FDA would be advantageous.

Halma India is a Great Place to Work certified organisation. Here's why working with us is fulfilling:

We offer a safe and respectful workplace , where everyone can be who they 'REALLY' are, feel free to bring their whole selves to work and use their unique talents, knowledge, expertise, experiences, & backgrounds to create meaningful outcomes.

We nurture entrepreneurial spirits and empower them to think beyond the possibilities, to discover, shape and build their own unique stories. Our diverse businesses and operations provide fulfilling opportunities to grow as individuals and make an impact.

We are simple, humble and approachable, and we believe in leadership at all levels to bring our purpose to life. Everyone at Halma India makes an impact, and so do you when you join us!

Halma India is an equal opportunity employer, which means the base of our recruitment decisions is always on skills, competencies, attitudes, and values. We are committed to hiring from diverse backgrounds without regard to age, ethnicity, religion, marital status, disability status, sex, gender identity, or sexual orientation.