Senior Associate - Design Control (MedTech)

TL;DR

Senior Associate - Design Control (MedTech): Managing lab test method validation, transfer plans, and Design History Files (DHF) with an accent on regulatory compliance (ISO 13485/21CFR 820). Focus on developing risk management plans, conducting FMEAs, and performing gap assessments for DHF remediation.

Company

A technology-led healthcare solutions provider enabling healthcare organizations to be future-ready.

What you will do

• Handle lab test method validation, transfer plans, protocols, and reports.
• Develop, draft, and maintain Design History Files (DHFs), including design inputs and verification plans.
• Create design verification protocols, reports, and development plans.
• Develop and review risk management plans, reports, and FMEAs to mitigate risks in design, transfer, and manufacturing.
• Perform gap assessments for DHF remediation and report findings.

Requirements

• Bachelor's degree (B.E. or B.Tech).
• Minimum 3 years of experience in medical device development, regulatory medical writing, or publishing medical content.
• Strong working knowledge of ISO 13485:2016 and/or 21CFR 820.
• Strong understanding of risk-based approach per ISO 14971.
• Excellent technical writing and medical device product documentation skills.
• Strong written and verbal communication and presentation skills.

Culture & Benefits

• Global fast-track career growth opportunities.
• Mentorship from some of the most brilliant minds in the industry.
• Entrepreneurial environment celebrating passion, innovation, collaboration, and empathy.
• Commitment to inclusion and diversity as an Equal Opportunity Employer.