International Regulatory Expert

5 days ago

Hyderabad, Telangana, India beBeeRegulatorySpecialist Full time ₹ 12,00,000 - ₹ 24,00,000
Job Title:

Regulatory Specialist

Job Description:

We are seeking a detail-oriented, experienced professional to support regulatory submissions and compliance initiatives in the medical device industry. The ideal candidate will have a strong understanding of international regulatory frameworks, with a focus on U.S. FDA and Health Canada requirements.

The successful applicant will be responsible for coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong communication and collaboration skills are essential for success in this role.

Required Skills and Qualifications:
  • Bachelor of Science in Biomedical Engineering, Life Sciences or a related field.
  • Minimum 3 years of regulatory experience in the medical device industry.
  • Proven experience contributing to regulatory filings.
  • Strong understanding of international regulatory body regulations.
  • Ability to interpret and apply regulatory requirements to complex technical issues.
  • Excellent communication, organization, and problem-solving skills.
  • Experience in supporting responses to regulatory agencies.
  • Ability to work independently and collaboratively in a cross-functional team environment.
Benefits:

This is an excellent opportunity for a motivated individual to develop their career in regulatory affairs. We offer a competitive compensation package, including a salary range of $80,000 - $120,000 per annum, depending on experience.

Others:

A background in Quality Engineering would be beneficial, as would experience in contributing to international regulatory submissions. RAC (Regulatory Affairs Certification) or similar professional certification is also desirable. Internal Auditor Training would be an advantage.

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