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

Western Digital

Technologist Software Development Engineering (DevOps) Job at Western Digital

 ...capture the first-ever picture of a black hole. We offer an expansive portfolio of technologies, HDDs, and platforms for business, creative professionals, and consumers alike under our Western Digital, WD, WD_BLACK, and SanDisk Professional brands. We are a key... 

UT Health East Texas

Flight Paramedic Job at UT Health East Texas

Overview: Join our team as a PRN Flight Paramedic in Tyler, TX. Why Join Us? Thrive in a People-First Environment and Make...  ...possess standard critical care skills commensurate with the flight nursing profession. Must become proficient in the operation of VHF... 

Purple Drive

QA Data Analyst Job at Purple Drive

 ...setsGood to have- Familiarity with data visualization tools Tableau | Power BIMust have depth knowledge in QA and manual testing ~7+...  ...to have experience working with large Data sets ~ Good to have- Familiarity with data visualization tools Tableau , Power BI... 

10-4 Logistics USA

CDL Truck Driver - No Experience Class A Training Provided Job at 10-4 Logistics USA

 ...Overview 10-4 Logistics USA is seeking full-time W2 Class A CDL drivers, including candidates with limited or no professional driving experience through a paid Class A training program. Positions are available across OTR, regional, and dedicated fleets, primarily east... 

Womble Bond Dickinson (US) LLP

Graphic Illustrator Job at Womble Bond Dickinson (US) LLP

Womble Bond Dickinson (US) LLP is seeking a Graphic Illustrator on the Trial Graphics Team in the Winston-Salem office who will be responsible for creating compelling graphics from an idea to a concept. Candidate will support the attorney in preparing for trial. Responsibilities...