Technical Engineer

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.