Job Description

🚀 We’re Hiring! — Technical Manager (RA/QA)
Location: Remote
CTC: Up to 15 LPA

Elexes is expanding, and we’re looking for an experienced Technical Manager – RA/QA to lead multiple teams, drive regulatory excellence, and elevate the quality and compliance standards across global medical device projects.

If you thrive in a fast-paced, cross-functional environment and enjoy steering complex regulatory and quality initiatives, we’d love to hear from you!

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🔧 Role Highlights

As a Technical Manager, you will:
• Provide strong leadership and partner with the Senior Manager to drive organizational success.
• Develop and execute delivery plans, ensuring clear communication with clients.
• Oversee and troubleshoot technical documentation across multiple concurrent projects.
• Shape and execute medium- and long-term strategic quality initiatives.
• Lead all phases of projects with full authority on regulatory and quality decisions.
• Forecast and manage resources across teams and ensure seamless project execution.
• Serve as the primary technical leader for cross-functional teams and client communications.
• Uphold QMS, regulatory requirements, and PM processes with diligence.
• Act as a QMS subject matter expert, contributing to audits, CAPA, and continuous improvement.
• Support global submissions and certifications such as 510(k), CE Marking, ISO 13485, ISO 9001, QSR, and more.
• Provide mentorship, on-the-job training, and technical guidance to RA/QA teams.
• Use AI tools to enhance project deliverables.
• Draft, review, and finalize SOWs, technical documents, and compliance requirements.
• Potentially serve as Management Representative (MR) when designated.

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📌 Key Involvement Areas

Clinical: CER, PMS, PSR
Product: Design Controls, SW/HW Documentation, Risk Assessments, V&V
Quality: QMS Compliance, Internal/External Audits, Certifications
Regulatory: 510(k), CE Marking, CDSCO, and other international submissions

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🎓 Desired Skills & Experience
• Bachelor’s Degree in Biomedical Engineering or a related field.
• 6+ years of independent project management experience for US FDA, EU MDR/IVDR, and TGA submissions.
• Strong global client communication and stakeholder management skills.
• Proven authorship of regulatory documentation across regulatory, quality, clinical, and product domains.
• Excellent written and verbal communication skills.
• Ability to quickly understand new medical device technologies, including PEMS and Software as a Medical Device (SaMD).

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📨 If this sounds like you, send your resume to:
👉 lisa@elexes.com