Regulatory Affairs Specialist

3 days ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title: Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have expertise in regulatory management and a strong understanding of medical device regulations.

About the Role:

This is an exciting opportunity for a talented professional to work with our international regulatory teams to understand their evolving business needs and provide guidance and support to implement solutions.

The successful candidate will collaborate with cross-functional teams to evaluate, recommend, and implement technology and platforms to manage licenses and process flows for multiple operating companies within the group.

You will also be responsible for minimising risk to business disruption from regulation and remaining agile and responsive to changing regulatory environments and evolving business needs.

Critical Success Factors:
  • Strong executional rigor and due diligence regarding documentation and process-oriented approach for day-to-day MDR licensing requirements.
  • Ability to understand varying needs across diverse stakeholders, especially different types of medical devices.
  • Excellent communication skills and ability to demonstrate commercial acumen when recommending solutions.
  • Demonstrate a deep and clear understanding of the evolving India MDR.
Qualifications and Experience:
  • Degree in Regulatory Management or related field.
  • Minimum 1-3 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.
  • Advantageous exposure to European MDR and FDA.

We offer a safe and respectful workplace where everyone can bring their whole selves to work and contribute meaningfully.

We believe in leadership at all levels and empower our employees to think beyond possibilities and build their unique stories.

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