Technical Engineer
Technical Engineer
Posted on :
29-09-2024
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Job Description
Title: Technical Engineer
Duration: Full Time Permanent
Client: FDA
Location: 100% Remote
Job Summary:
We are seeking a skilled Technical Engineer with extensive experience working with the FDA. The ideal candidate will play a critical role in ensuring compliance with regulatory requirements and supporting the development of innovative solutions in a dynamic environment. If you have a strong background in engineering and a passion for regulatory standards we want to hear from you!
Key Responsibilities:
- Collaborate with crossfunctional 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.
Qualifications:
- Bachelors 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 FDAregulated environments.
- Proven experience working directly with the FDA on regulatory submissions and compliance.
- Familiarity with relevant standards (e.g. ISOCFR Part 820).
- Strong analytical and problemsolving skills.
- Excellent communication and interpersonal skills with the ability to work collaboratively in a team environment.
- Detailoriented with a strong commitment to quality and compliance.
Employment Type
Full Time
Key Skills
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