Technical Specialist

8 hours ago

Rockville, Maryland, United States Trigent Solutions Full time
Job Overview

We are seeking a skilled Technical Engineer to join our team at Trigent Solutions. The ideal candidate will have extensive experience working with the FDA and a strong background in engineering and regulatory standards.

Key Responsibilities
  • Collaborate with cross-functional teams to ensure product compliance with FDA regulations.
  • Prepare and review technical documentation, including design specifications, validation protocols, and regulatory submissions.
  • Conduct risk assessments and facilitate design reviews to ensure product safety and efficacy.
  • Provide technical expertise in troubleshooting and resolving issues related to FDA compliance.
  • Monitor changes in regulatory guidelines and implement necessary updates to processes and documentation.
  • Support product development initiatives by providing engineering insights and regulatory knowledge.
  • Conduct training sessions for team members on FDA regulations and compliance best practices.
  • Participate in audits and inspections by regulatory bodies and ensure readiness for compliance assessments.
Requirements
  • Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field).
  • Minimum of 8 years of experience in a technical engineering role, with a strong emphasis on FDA-regulated environments.
  • Proven experience working directly with the FDA on regulatory submissions and compliance.
  • Familiarity with relevant standards (e.g., ISO 13485, 21 CFR Part 820).
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
  • Detail-oriented with a strong commitment to quality and compliance.

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