Regulatory Affairs Expert with Global Market Access

hace 2 semanas

Buenos Aires, Buenos Aires C.F., Argentina ITEX A tiempo completo
About the Company

Our client, a pioneer in high-tech medical and aesthetic devices, is renowned for its cutting-edge technology and commitment to innovation. With a global presence spanning multiple continents, this international organization is at the forefront of regulatory compliance and product safety.

Job Overview

In this pivotal role as a Regulatory Affairs Specialist, you will play a critical part in ensuring our client's medical devices meet all applicable regulations and standards worldwide. This requires close collaboration with regulatory bodies, internal departments, and customers to manage product registrations, maintain technical documentation, and support compliance processes.

Key Responsibilities
  • Global Compliance Management: Ensure that our client's medical devices comply with diverse national and international regulations.
  • Product Registrations: Coordinate and prepare product registrations and notifications within deadlines, maintaining accuracy and attention to detail.
  • Regulatory Communication: Effectively communicate with regulatory authorities for product registrations and updates, fostering strong relationships and resolving any issues promptly.
  • Technical Document Management: Prepare and maintain comprehensive technical files and other regulatory documents, guaranteeing their accuracy and accessibility.
  • Certificate Management: Obtain necessary certifications from notary offices and embassies for product approvals, streamlining the process and minimizing delays.
  • Customer Support: Provide valuable assistance to customers with product data and regulatory information, enhancing customer satisfaction and loyalty.
  • Export Compliance: Ensure compliance for product exports, including managing Certificates of Origin, to avoid any potential issues or penalties.
  • Interdepartmental Collaboration: Work closely with marketing, purchasing, and engineering teams to ensure regulatory requirements are met, promoting a cohesive and efficient workflow.
  • Document Issuance: Handle the issuance of Free Sale Certificates and other required regulatory documents, guaranteeing timely delivery and accuracy.
  • Economic Operator Registration: Support the registration of Economic Operators in the EUDAMED database, facilitating smooth operations and compliance.
  • Language Translation: Translate regulatory documents between Slovak and English when necessary, ensuring seamless communication and understanding.
  • Quality Standards: Ensure compliance with organizational quality, environment, and health and safety standards, upholding the company's values and reputation.
Requirements
  • Academic Background: Hold an academic degree in life sciences, chemistry, or technical/engineering education.
  • Work Experience: Possess at least 2 years of experience in a similar regulatory affairs position, demonstrating expertise and adaptability.
  • Regulatory Knowledge: Have extensive knowledge of regulatory issues and experience interfacing with local and international regulatory bodies.
  • Computer Skills: Possess advanced computer skills, particularly in MS Office applications.
  • Medical Writing (Optional): Having experience in medical writing can be beneficial but is not mandatory.
  • Language Proficiency: Be proficient in English (C1 level) and possess proficiency in Slovak (C2 level).
Additional Skills
  • Attention to Detail: Demonstrate high attention to detail and analytical skills to ensure accuracy and precision in all tasks.
  • Organizational Skills: Exhibit strong organizational skills to prioritize tasks, manage time effectively, and meet deadlines.
  • Communication Skills: Possess excellent writing and communication skills to convey complex ideas clearly and concisely.
  • Teamwork: Display a team player attitude, fostering strong interpersonal relationships and cooperation with colleagues.
What We Offer
  • Competitive Salary: Enjoy a competitive salary commensurate with your skills and experience.
  • Performance-Based Benefits: Receive a 13th salary in Q1 based on both company profits and individual employee performance.
  • Reimbursement: Get reimbursement for commuting expenses, easing your financial burden.
  • Great Work Environment: Thrive in a dynamic office environment with a supportive team culture.

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