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