Regulatory Compliance Specialist

hace 4 semanas


Madrid, Madrid, España Vision Achievement A tiempo completo
Job Summary

At Vision Achievement, we are seeking a highly skilled Regulatory Compliance Specialist to join our team on a fully remote basis. This is a full-time position with a competitive salary and benefits package.

About the Role

The Regulatory Compliance Specialist will be responsible for managing and overseeing all aspects of a client company's Clinical Evaluation Report (CER), Biological Evaluation Report (BER), and Post-Market Surveillance (PMS) processes and documentation. This includes research and analysis, developing and maintaining documentation, and ensuring compliance with all relevant regulations and standards. Key responsibilities include:
  • Developing and maintaining comprehensive knowledge of CER, BER, and PMS regulations and standards, including MDR, MEDDEV, and ISO requirements;
  • Conducting thorough research and analysis to gather necessary data and information for CER, BER, and PMS processes and documents;
  • Collaborating with cross-functional teams to ensure timely and accurate completion of CER, BER, and PMS documents;
  • Developing and maintaining documentation, including protocols, reports, and other necessary documents;
  • Providing guidance and support to other team members on CER, BER, and PMS processes;
  • Staying updated on industry trends and changes in regulations and standards related to CER, BER, and PMS.

Requirements

To be successful in this role, you will need:
  • A Bachelor's degree in a relevant field, such as life sciences or engineering;
  • A minimum of 3-5 years of experience in CER, BER, and PMS documentation, preferably in the medical device industry;
  • Strong knowledge of regulations and standards related to CER, BER, and PMS, including MDR, MEDDEV, and ISO requirements;
  • Strong attention to detail and ability to manage multiple projects simultaneously;
  • Excellent communication and interpersonal skills;
  • Ability to work independently and in a team environment.

Benefits

Vision Achievement offers a competitive salary and benefits package, including health insurance, retirement savings plan, and opportunities for professional growth and development. We are an equal opportunity employer and welcome applications from diverse candidates.

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