CER / BER / PMS Specialized

ELIQUENT Life Sciences, a leading specialized company in Washington D.C., is seeking a highly qualified and experienced CER / BER / PMS Specialist to join our team on a fully remote basis. This is a full-time position with competitive salary and benefits.

The CER / BER / PMS Specialist 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. This includes research and analysis, developing and maintaining documentation, and ensuring compliance with all relevant regulations and standards.

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 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