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

Guru Schools

Power BI Developer Job at Guru Schools

Position Title * Power BI Developer Position Responsibilities LOOKING FOR SENIOR POWER BI DEVELOPER 3 DAYS ON SITE MUST BE IN THE DC METRO AREA STRONG POWER BI AND DAX EXPEREINCE

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...

Matt Giambo

LPN Job at Matt Giambo

 ...and release instructions Requirements Proven experience as LPN or similar role Ability to undertake a variety of diverse...  ...tasks and work in a multidisciplinary team Familiarity with hospital health, safety and sanitation standards and procedures Understanding... 

Goodwill Mid Michigan

Career Coach Job at Goodwill Mid Michigan

 ...Goodwill Industries of Mid-Michigan is lookingto fill a Full-TimeCareer Coach position in Genesee County . $17.13 an hour plus20% discount on in-store purchases. Career Advancement Opportunities!!__________________________________________________... 

Saint Francis Hospital

Sitter Job at Saint Francis Hospital

Overview Department: Nursing Float Pool Shift: Full time, Nights, 7pm-7am Hospital: Saint Francis Hospital Location: Evanston, IL 60202 Responsibilities Maintains responsibility to sit with and observe the patient and his/her surrounding environment...