Regulatory & Clinical Associate at Primesage Innovation Center

Role Overview

• We are seeking a highly motivated Regulatory & Clinical Associate (Master’s or PhD level) to support the preparation of regulatory submissions and clinical evidence documentation for medical devices.
• This role combines regulatory drafting, compliance research, and clinical evaluation writing. The associate will work under the guidance of a project manager and principal consultant.

Job Responsibilities

• Draft and format regulatory submission documents (e.g., 510(k), MDR, technical documentation).
• Conduct literature searches and summarize findings in structured formats.
• Draft Clinical Evaluation Plans (CEP), Reports (CER), Post-Market Clinical Follow-Up (PMCF) plans/reports, and Summaries of Safety and Clinical Performance (SSCP).
• Prepare clear draft email updates summarizing project status and next steps (to be sent by the principal consultant).
• Follow established templates, SOPs, and version-control systems.
• Flag discrepancies, risks, or missing information to the project manager/principal.

Qualifications

• Candidates should possess a Master’s or PhD in Biomedical Sciences, Regulatory Affairs, Clinical Research, or a related field (required).
• Strong background in technical and/or scientific writing.
• Experience with literature reviews, clinical documentation, or regulatory processes.
• Excellent written English, detail-oriented, and reliable.
• Ability to work independently while following structured processes.