Software As A Medical Device Specialist

SAMD Specialist

Exp 3 to 12 years

Location- Bangalore/pune/ Chennai/Hyderabad

JD

1. Bachelor's degree in relevant field (or equivalent experience)
2. 6 - 8 years working in a regulated industry (FDA and Software as a Medical Device preferred).
3. Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
4. Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings. Filings for Software as Medical Device preferred.
5. Experience with US FDA Class I and II medical devices. Additional experience with FDA Class III devices and OUS device classification a plus.
6. Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections.

Mandatekey skills:

• FDASubmissions
• 510(k)
• EUAIAct

Company Description

PRIMUS Global Technologies Pvt. Ltd., headquartered in the US, is a rapidly growing IT services and staffing firm. With operations in Bangalore, Hyderabad, Vizag, and Pune, the company has established a significant presence within India. Globally, PRIMUS employs over 3000 IT professionals working on diverse projects. The organization emphasizes delivering innovative technology solutions and staffing expertise to meet the evolving demands of clients worldwide.

Role Description

This is a full-time on-site role for a Software as a Medical Device Specialist located in Bengaluru South. The role involves overseeing the lifecycle of software as a medical device (SaMD), including development, testing, compliance, and deployment. The specialist will ensure adherence to regulatory frameworks, conduct risk assessments, and collaborate with cross-functional teams to maintain quality standards. Additionally, responsibilities include maintaining technical documentation, addressing software updates, and implementing cybersecurity measures for medical software solutions.