Senior Technical Writer Job at United Consulting Hub, North Carolina

TVBjbmxJUTFpaWZOTjZlWEY2NHZHblRpdXc9PQ==
  • 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

ExecutivePlacements.com

Data Analyst(Entry/Junior Level) Job at ExecutivePlacements.com

Job Opportunity At SynergisticIT SynergisticIT understands the complex nature of the job market and how difficult it can be to secure a position, especially for fresh graduates. Therefore, we assist and help tech-savvies to convert their passions into professions. We...

Grosvenor Enterprise LLC

Mail Delivery Driver (1099 Contractor) Job at Grosvenor Enterprise LLC

 ...Overview We are seeking a dedicated and reliable Mail Delivery Driver (Independent Contractor) to join our team. In this role, you...  ..., must be able to lift and carry heavy sacks of mail and walk long distances. Join our team as a Driver (Independent Contractor) where... 

MedPro Healthcare Allied Staffing

Travel Operating Room Certified First Assistant (CSA/CSFA) Job at MedPro Healthcare Allied Staffing

Job Description MedPro Healthcare Allied Staffing is seeking a travel Surgical First Assistant for a travel job in Martinsburg, West Virginia. Job Description & Requirements ~ Specialty: Surgical First Assistant ~ Discipline: Allied Health Professional ~ ...

Homegeniusexteriors

HGE WEBSITE Field Marketing Expert - MIDA Job at Homegeniusexteriors

Ready to Kickstart Your Sales Career with Home Genius Exteriors?Are you a recent graduate looking to jump into a dynamic sales career? Do you have a competitive mindset and love interacting with new people? Home Genius Exteriors is expanding and needs ambitious, energetic...

KIPP ENC PUBLIC SCHOOLS INC

[2025 - 2026] 4th Grade Math Lead Teacher KIPP Pride 3-5 Job at KIPP ENC PUBLIC SCHOOLS INC

 ...Description Organizational Overview Every School. Every Student. Every Day. Knowledge...  ...the doors of our schools. Especially our teachers. Their skill. Energy. Love. Their...  ...lesson delivery to execute curriculum at a high level while following the pacing guide with...