Global Regulatory Strategy Specialist

2 days ago

Bengaluru, Karnataka, India beBeeExcellence Full time US$ 1,72,742 - US$ 2,08,859
Regulatory Affairs Expert

The ideal candidate will have a deep understanding of regulatory requirements and strategies to ensure compliance with industry standards. In this role, you will be responsible for developing and implementing global regulatory strategies, working closely with cross-functional teams to ensure alignment with organizational objectives.

Key Responsibilities:
  • Develop and implement global regulatory strategies to ensure compliance with industry standards.
  • Collaborate with cross-functional teams to ensure alignment with organizational objectives.
  • Ensure adherence to company policies and regulatory requirements.
  • Develop and manage regulatory submissions, including U.S. FDA 510(k) pre-market notification submissions and FDA Pre-Submissions (Q-Subs).
  • Monitor and handle potential regulatory impacts on product safety, implementing continuous improvement processes within the regulatory framework.
  • Coordinate and facilitate witness testing to ensure products comply with safety regulations.
  • Support the development of the regulatory plan, offering guidance on risk assessment and necessary corrective actions to meet regulatory requirements.
  • Develop and facilitate regulatory submissions for both new and existing products/solutions, ensuring accuracy and completeness to expedite regulatory approval processes effectively.
  • Recommend enhancements in systems and processes to solve problems or improve effectiveness of job area by collaborating with other functions.

Requirements:
  • Minimum required Education: Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
  • Minimum required Experience: Minimum 8-10 years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent.

Benefits:
  • Competitive salary and benefits package.
  • Opportunity to work with a dynamic team and contribute to the growth and success of the organization.
  • Professional development opportunities, including training and education programs.

Why Join Us?

We are a health technology company dedicated to improving the lives of billions of people every year. We believe that life is better when #youareyou, and we strive to create an inclusive and diverse workplace culture that values and respects individual differences.

Our hybrid working model is designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. We encourage collaboration and innovation, and we are committed to making a positive impact in the world.

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