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