The Medical Writer will possess an understanding of regulatory requirements for clinical evaluation, post-market clinical follow-up (PMCF) documentation, and related deliverables
Job Summary
The Medical Writer will possess an understanding of regulatory requirements for clinical evaluation, post-market clinical follow-up (PMCF) documentation, and related deliverables.
Prepare and update EU Clinical Evaluation Reports (CERs) and summarize relevant literature to support technical files, dossiers, registrations, and other regulatory documentation in accordance with applicable SOPs, regulations, and guidance documents.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.
Matching Summary
The Medical Writer will possess an understanding of regulatory requirements for clinical evaluation, post-market clinical follow-up (PMCF) documentation, and related deliverables.
Skills & Requirements
Must-have
Regulatory requirements for clinical evaluation
Post-market clinical follow-up documentation
Develop high-quality documents
Scientific literature reviews
EU Clinical Evaluation Reports (CERs)
Nice-to-have
Collaborate effectively with cross-functional stakeholders
Anticipate issues and minimize impacts
Learn, grow, and become your best self
Find purpose in the possibilities
Key Requirements
Bachelor’s degree in sciences or medical-related field
1-3 years medical device experience OR 5 years medical device experience
Experience or understanding of scientific or clinical research