Primesage Innovation Center is an international standard Human capital development firm with a knack for excellence in service executed by wisdom.
Regulatory & Clinical Associate
- Job Type: Part Time , Remote
- Qualification: MBA/MSc/MA , PhD/Fellowship
- Experience
- Location: Nigeria
- Job Field: Medical / Healthcare
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.
Method of Application
Interested and qualified candidates should send their CV and Cover Letter to: primesageconsulting@gmail.com using the Job Title as the subject of the mail.
