Regulatory Compliance Specialist

hace 3 días

Bogotá, Bogotá D.E., Colombia Coopervision A tiempo completo

**Job Summary:**
We are seeking a highly skilled Regulatory Compliance Specialist to join our team at CooperVision. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with local and global regulations related to medical devices.

**About the Role:**
In this exciting role, you will have the opportunity to work on a wide range of tasks, including evaluating technical documents, preparing regulatory labeling requirements specifications, and reviewing product labeling to ensure compliance. You will also be responsible for retrieving, reviewing, and requesting packaging materials and samples as necessary, as well as tracking legal documents for regulatory submissions. Additionally, you will provide support to the RAQA manager in the department's activities, gather information for submission of new registrations, variations, and renewals of CooperVision products, and communicate & submission of documentation as required.

**Responsibilities:**

  • Evaluate technical documents, change controls, dossiers, gap assessments, etc.
  • Prepare regulatory labeling requirements specifications for new and modified products.
  • Review product labeling to ensure compliance when required.
  • Retrieve, review, and request packaging materials and samples as necessary.
  • Track legal documents for regulatory submissions.
  • Provide support to the RAQA manager in the department's activities.
  • Gather information for submission of new registrations, variations, and renewals of CooperVision products.
  • Communicate & submission of documentation as required.

**Requirements:**
To be successful in this role, you will need to have a strong understanding of local and global regulations relevant to medical devices. A minimum of 5 years' experience in Regulatory Affairs and Quality Assurance is required, with a minimum of 2 years in the position. You must also have advanced knowledge in Microsoft Office Suite, including Word, PowerPoint, and Excel, as well as excellent written and verbal communication skills and interpersonal relationship skills. Good problem-solving, decision-making, organizational, analytical, and critical thinking skills are also essential.

**What We Offer:**
We offer a competitive salary of $80,000 - $120,000 per year, depending on experience, plus comprehensive benefits and a special focus on wellness. Our commitment to our core values and a diverse, inclusive, employee-centric culture fuel a deeply engaged, high-performing organization. If you're passionate about regulatory affairs and quality assurance, and want to join a dynamic and innovative team, we encourage you to apply for this exciting opportunity

**Note:**
This job requires prolonged sitting in front of a computer and occasional trips, less than 5% of the time.

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