Regulatory Affairs Executive

4 weeks ago

Bengaluru, Karnataka, India Halma plc Full time
About Halma:

Halma is a global group of life-saving technology 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 specialize in market leading technologies that push the boundaries of science and technology.

For the last 42 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ≥ 5% every year– an achievement unrivalled by any company listed on the London Stock Exchange.

Why join us?

We are a Great Place to Work certified organization, with an employee centric culture anchored on autonomy, trust, respect, humility, work-life balance, team spirit, and approachable leadership.

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, and 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. We promote and support non-linear career growth for the right talent.

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

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.
- Minimize 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.

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