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CER BER PMS Specialist

2 months ago

Washington, Washington, D.C., United States Vision Achievement Full time

Job Summary:

Vision Achievement is seeking a highly qualified and experienced CER / BER / PMS Specialist to join our team in a full-time capacity. This role will be responsible for managing and overseeing all aspects of a client company's CER (Clinical Evaluation Report), BER (Biological Evaluation Report), and PMS (Post-Market Surveillance) processes and documentation.

Key Responsibilities:

  • Develop and maintain comprehensive knowledge of CER, BER, and PMS regulations and standards, including MDR, MEDDEV, and ISO requirements.
  • Conduct thorough research and analysis to gather necessary data and information for CER, BER, and PMS processes and documents.
  • Collaborate with cross-functional teams to ensure timely and accurate completion of CER, BER, and PMS documents.
  • Develop and maintain documentation, including protocols, reports, and other necessary documents.
  • Provide guidance and support to other team members on CER, BER, and PMS processes.
  • Stay updated on industry trends and changes in regulations and standards related to CER, BER, and PMS.

Qualifications:

  • Bachelor's degree in a relevant field (e.g., life sciences, engineering).
  • Minimum of 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.