• To be able to convert any candidate, they must sit onsite at a designated location stated above- not interested in fully remote workers at this time.
• Medical Device MDR compliant CERs, CEPs and SSCPs for Structural Heart and Neuromodulation Class III devices
• The Medical Principal Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process.
• Daily activities are related to authoring Clinical Evaluation Reporting documents for the Neuromodulation, CAHF and Vascular products.
• Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed.

Top 3 Skills or Any Specific type of Experience you are looking for:

• Experience writing Medical Device MDR compliant CERs, CEPs and SSCPs
• Microsoft Office proficiency
• Structural Heart, Neuromodulation, or other medical device experience such as Clinical Study Management

Education: A bachelor’s degree is required along with 6-8 years of experience.

Successful Backgrounds:

• Bachelor’s Degree or an equivalent combination of education and work experience
• 6-8 years of medical writing experience in the medical or pharmaceutical industry or 8+ years general technical writing experience required
• Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry , or combination of these skills

Preferred

• Biomedical, sciences, medicine or similar health related discipline preferred