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 fulltime position with competitive salary and benefits.

The CER / BER / PMS Specialist will be responsible for managing and overseeing all aspects of a client companys CER (Clinical Evaluation Report) BER (Biological Evaluation Report) and PMS (PostMarket 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 crossfunctional 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:

Bachelors degree in a relevant field (e.g. life sciences engineering)

Minimum of 35 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

Remote Work :

No