Senior Medical Writer & Clinical Evaluation Lead

Regulatory Jobs; Santa Clara (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Strong retirement plan with high match

Tuition reimbursement

Education benefit program

Diversity and inclusion recognition

Job summary

Abbott is seeking a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to join the Vascular Division on-site in Santa Clara, CA. You will combine scientific methodology, regulatory knowledge, and product understanding to support EU CE marking and maintain CE marking under MEDDEV 2.7/1 Rev 4 and EU MDR 2017/745.

The role requires creating CERs/SSCPs, evaluating clinical evidence, and guiding regulatory responses with cross-functional teams.

Qualifications

• Bachelor's degree in a scientific/engineering/medical field, with strong methodology background.
• Thorough understanding of EU MDR 2017/745, MDD, MEDDEV 2.7/1 Rev 4 and related guidelines.
• Experience in project management and delivering regulatory documents on time.
• Excellent written, verbal, and presentation skills in clinical/technical contexts.
• Strong medical terminology knowledge; able to adapt to changing priorities.

Responsibilities

• Independently creates and maintains Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCPs.
• Summarizes clinical evidence from investigations, literature, and post-market data for regulatory submissions.
• Manages timelines and communicates risks and mitigation strategies across teams.
• Interprets results for product applications and QA alignment and guides regulatory responses.

Skills

Bachelor's degree

Scientific background

EU MDR 2017/745 knowledge

Project management

Written/verbal communication

Medical terminology

Travel availability

Education

Master's degree, RN, PharmD, PhD, or MD preferred

Job description

Abbott is seeking a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to join the Vascular Division on-site in Santa Clara, CA. You will combine scientific methodology, regulatory knowledge, and product understanding to support EU CE marking and maintain CE marking under MEDDEV 2.7/1 Rev 4 and EU MDR 2017/745.

The role requires creating CERs/SSCPs, evaluating clinical evidence, and guiding regulatory responses with cross-functional teams.