CER Writing/Analyst

Job Summary:

We are seeking a highly motivated and experienced CER Writing/Analyst. In this role, you will be responsible for conducting clinical evaluations and writing Clinical Evaluation Reports (CERs) for our medical devices in accordance with applicable regulations and guidelines. You will work closely with cross-functional teams, including regulatory affairs, clinical affairs, R&D, and quality to ensure timely and accurate completion of CERs.

Key Responsibilities:

Conduct clinical evaluations for medical devices in accordance with applicable regulations and guidelines (e.g., MEDDEV 2.7/1 rev. 4, MDR).

Write and edit CERs in accordance with applicable regulations and guidelines.

Collaborate with cross-functional teams to ensure timely and accurate completion of CERs.

Conduct literature reviews and stay up to date with the latest developments in medical device regulations and guidelines.

Maintain and update the company's CER templates, procedures, and related documents.

Participate in regulatory and notified body audits related to CERs.

Provide support to regulatory affairs, clinical affairs, R&D, and quality teams as needed.

Qualifications:

Bachelor's or Master's degree in a relevant field such as biomedical engineering, life sciences, or a related field.

3-5 years of experience in CER writing and clinical evaluations in the medical device industry.

Knowledge of applicable regulations and guidelines related to CERs (e.g., MEDDEV 2.7/1 rev. 4, MDR).

Excellent writing, editing, and analytical skills.

Strong attention to detail and ability to manage multiple projects simultaneously.

Ability to work independently and as part of a cross-functional team.

Proficiency in literature review and data analysis.

Experience with statistical analysis software (e.g., SAS, R) is a plus.

Excellent communication and interpersonal skills.

If you have a passion for medical devices and enjoy working in a collaborative environment, we encourage you to apply for this exciting opportunity.

PRECISION LIFE SCIENCES - PRECISION TALENT GROUP