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

Kempsville Center for Behavioral Health

RN Job at Kempsville Center for Behavioral Health

 ...Behavioral Health, we require all employees to be fully vaccinated. Per CDC guidelines, approved or authorized vaccinations include: Johnson & Johnson Janssen, Moderna, and Pfizer-BioNTech. If an offer is extended, please have proof of vaccination on or before New... 

Class A Jobs 411

CDL-A Trainee Truck Driver | Paid Training Available | Memphis, TN Job at Class A Jobs 411

 ...CDL-A Trainee Truck Driver | Paid Training Available | Memphis, TN No Experience Required Start Earning Immediately If you are ready to launch a long-term trucking career, our CDL-A trainee program serving drivers in and around the Memphis, Tennessee metro area... 

Ansible Government Solutions

Vascular Surgeon (Physician) Job at Ansible Government Solutions

 ...Overview Ansible Government Solutions, LLC (Ansible) is currently seeking a Vascular Surgeon to support operations at the Oklahoma City VA Medical Center located at 921 NE 13th St., Oklahoma City, OK 73104. Full-time and Locum Tenens positions with generouscompensation... 

Abacus Solution Group

Peer Recovery Support Specialist - REQ 47132 Job at Abacus Solution Group

 ...Peer Recovery Support Specialist - Virginia Beach Sunday - Thursday 2:00pm - 10:30pm Pay rate: $19.75 per hour Please: only apply if you have peer recovery experience of 6 months+ Responsible for provision of support services to adults with substance use disorders... 

JETT Medical Staffing

Nurse Practitioner - Orthopedic Surgery - Locum Job at JETT Medical Staffing

 ...We are seeking an Orthopedic Surgery NP for locum coverage in Idaho. Mar 2 2026 - Ongoing Scheduled + On Call EMR: Epic ID license required We provide excellent weekly compensation, cover all travel expenses, offer A+ rated malpractice Insurance, and...