Senior Technical Writer Job at United Consulting Hub, North Carolina

ZHZrdG1KdmhIVGd0OVIwMjY0WmNyTlUwWVE9PQ==
  • United Consulting Hub
  • North Carolina

Job Description



Job Title: Senior Technical Writer
Location: NC
Doration: 5 Months



Key Responsibilities:

  • Prepare, update, and maintain PSURs to ensure compliance with EU MDR 2017/745, FDA, and other international regulatory standards.
  • Collect and analyze safety and post-market surveillance data from internal and external sources.
  • Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, Clinical, and Risk Management to ensure accurate and timely reporting.
  • Conduct literature reviews and integrate findings into PSURs.
  • Ensure all PSURs are written clearly, concisely, and scientifically, aligning with regulatory requirements.
  • Maintain version control, document management, and audit readiness of PSURs.
  • Assist in writing and editing risk management reports, clinical evaluation reports (CERs), and other regulatory submissions as needed.
  • Stay up to date with evolving regulations, guidance documents, and best practices related to post-market surveillance and regulatory reporting.

Qualifications & Skills:

  • Bachelor's or Master's degree in a scientific, technical, or medical field (e.g., Life Sciences, Biomedical Engineering, Regulatory Affairs).
  • 5+ years of experience in technical writing, regulatory writing, or post-market surveillance in the medical device or pharmaceutical industry.
  • Strong understanding of EU MDR (Article 86), ISO 13485, ISO 14971, FDA regulations, and other relevant global requirements.
  • Experience in analyzing safety data, clinical literature, and regulatory reports.
  • Proficiency in Microsoft Office Suite, document management systems (DMS), and regulatory submission tools.
  • Excellent written and verbal communication skills, with the ability to translate complex data into clear, structured reports.
  • Strong project management skills with the ability to manage multiple deadlines in a fast-paced environment.
  • Experience working with cross-functional teams and regulatory bodies is a plus.

Job Tags

Similar Jobs

Ainsworth Community Schools

Special Education Teacher Job at Ainsworth Community Schools

 ...Ainsworth Community Schools (ACS) is seeking applicants for an Elementary Special Education Position to begin in August 2026. This position is primarily lower elementary, but could span to upper-grade levels if needed or depending on candidates. ACS is a Class D1/C... 

Palos Hospital

Lactation Consultant RN-Perinatal Full Time Rotating Job at Palos Hospital

 ...insurance ~ Annual Employee Salary Increase and Incentive Bonus ~ Paid time off and Holiday pay Description The Lactation Consultant RN reflects the mission, vision, and values of NM, adheres to the organizations Code of Ethics and Corporate Compliance... 

GreatAuPair LLC

Personal Assistant Job at GreatAuPair LLC

 ...communicate, editing documents, house cleaning and being my assistant for foreign clients. This position guarantees room and board with pay negotiable with Visa options sponsored by my company. Ideal candidate is someone responsible, honest, organized, and professional.

KBR

Action Officer Job at KBR

 ...Title: Action Officer Belong. Connect. Grow. with KBR! KBR's National Security Solutions team provides high-end engineering and advanced technology solutions to our customers in the intelligence and national security communities. In this position, your work will... 

Two95 International Inc.

Senior Business Analyst Job at Two95 International Inc.

 ...Minimum work experience:8 - 10 Years Mandatory Skills: Functional Business Analysis, Statistical Analysis, Business Analytics, SAS for Statistics, Statistical Modeling Desirable Skills: T hird Party Logistics - Supply Chain Management Note: If...