Job Summary:

The Medical Technical Writer is responsible for providing oversight and execution of European Union (EU) Clinical Evaluation Plans, Reports (CEP/CERs) and the Periodic Safety Update Reports (PSUR) for all products. They will also be responsible for the preparing and drafting of any post market correspondence to Health Authorities.

 

Job Details:

1. Plan and help write CEPs, CERs and PSURs along with PMS Engineers and consultants
2. Conduct technical reviews to ensure document accuracy and compliance to local procedures, and regulatory requirements.
3. Drafting white papers.
4. Prepare draft and final correspondence with Health Authorities.
5. Partner with cross-functional team members to address the needs of each contributor.
6. Creates, writes, and edits high quality text following corporate and department style guidelines while following project guidelines, documentation standards, and templates.
7. Participate in workshops and other initiatives to help define and continuously improve process efficiency.
8. Participate in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices.
9. Support and, at times, act as a subject matter authority during audits and inspections pertaining to processes and reports.
10. Performs other job-related duties as assigned.

 

Knowledge, Skills, and Abilities:

• Strong verbal and written communication skills and interpersonal relationships are required.
• Strong drive to achieve results and meet commitments.
• Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation is required.
• Ability to take high degree of initiative and demonstrates motivation to work independently and be a self-starter.
• Ability to work with cross-departmental teams.

 

Background, Experiences:

• BA, BS, or BSN is required in areas of Engineering, Nursing, Biomedical Engineering, or other life science discipline. An advanced degree is preferred.
• Minimum of 5 years related job experience with a BA, BS, or BSN; or minimum of 3 years related job experience with an advanced degree is required.
• Demonstrated knowledge in quality regulatory compliance, adverse event reporting, medical device risk management processes, and common statistical methods is preferred.
• Regulatory/Notified Body audit experience is preferred.