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Medical Device Compliance Specialist

2 weeks ago

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Regulatory Affairs Role at Teleflex

We are seeking an experienced Sr. Regulatory Affairs Associate to join our team in the EMEA region. As a key member of our regulatory affairs department, you will play a critical role in ensuring the regulatory compliance and approval of our medical products.

Responsibilities:
  1. Regulatory Coordination: Coordinate and manage regulatory activities to ensure timely completion and adherence to international regulatory requirements.
  2. Project Work: Participate in project work such as new product introductions, changes to existing products and processes, and other regulatory/company projects as required.
  3. Documentation Preparation: Prepare internal reports, change control documents, and review documents for potential impact on global regulatory submissions.
  4. Product Registration: Prepare product registration files for submission to global regulatory bodies/agencies to obtain product approvals and maintain regulatory compliance with international regulatory requirements.
  5. Tender Applications: Prepare information to support Product Tender Applications in the international markets and to support customer services with the shipment of products.
  6. Audit Support: Support internal and external audits, ensuring that all regulatory requirements are met.
Requirements:
  • Degree in Science or Engineering: Degree in a relevant Science or Engineering discipline required.
  • Medical Device Experience: 2-3 years medical device industry experience within quality or regulatory desired.
  • Technical Writing: Technical writing expertise required.
  • Regulatory Knowledge: Basic knowledge and understanding of US and/or international medical device regulations, standards, and guidance documents.
  • Project Management: Project Management skills and experience required.
What We Offer:
  • Career Development: Opportunities for career development and growth within the company.
  • Work-Life Balance: Flexible working arrangements to support work-life balance.
  • Collaborative Team Environment: Collaborative team environment with opportunities to work with cross-functional teams.