Regulatory Compliance Specialist

hace 5 días


Añasco, Puerto Rico Labchems Corp. A tiempo completo

About the Role:

We are seeking a highly skilled Regulatory Compliance Specialist to join our team in support of the EU MDR program. As a key member of our team, you will play a critical role in ensuring compliance with regulatory requirements.

Key Accountabilities:

  1. Support data gathering and analysis to inform remediation plans.
  2. Conduct gap assessments to identify areas for improvement.
  3. Develop and execute remediation plans to address identified gaps.
  4. Maintain accurate and detailed records of all activities.

Essential Qualifications:

  • Bachelor's degree in Engineering, Science, or related field.
  • At least 7-10 years of experience in validation activities and/or project management.
  • Strong knowledge of regulatory agency guidelines.
  • Excellent analytical and problem-solving skills.
  • Proficient in Microsoft Project.

Preferred Qualifications:

  • Familiarity with Medical Device Regulation (MDR).
  • Fluency in Spanish and English.
  • Experience working in a regulated environment.


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