Regulatory Compliance Specialist

1 week ago


Dubai, Dubai, United Arab Emirates Cordis, LLC Full time

Job Summary

Cordis, LLC is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring product regulatory compliance with applicable regulations and standards in the Middle East and Africa (MEA) region.

Key Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with Cordis products worldwide and support company growth.
  • Support and advise on assessment project tasks relevant to regulatory affairs from product inception to product launch and post-market survey.
  • Oversee the overall registration strategies, coordination, implementation, execution, control, and completion of product registrations in all MEA countries.
  • Ensure personal and company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
  • Participate in the review of Cordis marketing material that references products and/or disease state information to ensure overall product compliance.
  • Conduct regular surveys to interpret new regulatory requirements as they relate to company products and procedures.
  • Provide solutions to a variety of problems of limited scope and complexity.
  • Provide Regulatory intelligence.
  • Perform regular supplier audits (Desktop or audit based on ISO standards).
  • Support communication with local agents and distributors in the countries.
  • Responsible for communicating business-related issues or opportunities to the next management level.
  • Maintain and archive all regulatory documentation.
  • Register new products in assigned countries.
  • Report Serious Adverse Events occurring in clinical studies to Competent Authority(ies) in MEA when required and communicate with the CAS.
  • Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
  • Ensure compliance with Quality Procedures, Laws, and Regulations of the applicable markets.
  • Perform other duties assigned as needed.

Requirements

  • BA/BS in Scientific discipline or equivalent work experience (2 years min).
  • Desired MA/MS in Medicines, Biology, Pharmacy.
  • 2-4 years of related experience in Regulatory Affairs or Quality Affairs in the Medical Devices area in MEA countries.
  • Consistent background and knowledge of MD regulations.

About Cordis, LLC

Cordis, LLC is an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. We strive to create and maintain working and learning environments that are inclusive, equitable, and welcoming.



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