Regulatory Affairs Specialist
4 months ago
Why join us?
We are a Great Place to Work® certified organisation,
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.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.
Qualifications:Degree in Regulatory Management.
Experience:Minimum 6 to 8 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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