Yousufguda Hyderabad Telangana Engineer Jobs – 2061 Open Jobs Today

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Regulatory Affairs Engineer – Medical Devices (Electronics & Mechanical)

PlebC Innovations Private Limited
Gachibowli, Hyderabad, Telangana

Quick apply

Job details

Permanent | Full-time
₹2,40,000 - ₹5,00,000 a year

Qualifications

Mechanical engineering
Schematics
Quality management
Diagnostic evaluation
Bachelor's degree
Cybersecurity
Document management
Communication skills
Mechanical knowledge
FDA regulations

Full job description

Regulatory Affairs Engineer – Medical Devices (Electronics & Mechanical)

Location: Hyderabad (On-site)
Company: PlebC Innovations Pvt Ltd
Employment Type: Full-Time
Experience Level: Open to Freshers and Experienced Candidates (0–5 years)—compensation commensurate with experience.

About the Company

PlebC Innovations is a deeptech startup developing TORUS (Tele-Operated Robotic Ultrasound System). Our mission is to bridge the healthcare gap in remote and underserved areas by enabling "Diagnosis from a Distance.

About the Role

We're hiring our first dedicated regulatory affairs engineer to build out regulatory documentation and quality processes alongside our engineering teams as the product moves toward submission-readiness. This is a hands-on, build-it-yourself role — you'll work directly with the founding/technical team rather than within an existing QA/RA department, with full ownership of the regulatory function as it's established at PlebC.

Key Responsibilities

Prepare, review, and maintain regulatory documentation for TORUS as it moves through design and V&V.

Build and maintain Design History File (DHF), Device Master Record (DMR), Technical File, and Risk Management File — largely from scratch, in collaboration with engineering teams.

Support compliance activities related to:

ISO 13485 (Quality Management Systems)
ISO 14971 (Risk Management)
IEC 60601 Series (Electrical Safety)
IEC 62304 (Software Lifecycle)
IEC 62366 (Usability Engineering)
MDR (EU Medical Device Regulation)
CDSCO Medical Device Rules (India)
FDA 21 CFR Part 820 (Quality System Regulation)

Coordinate directly with Mechanical, Electronics, Embedded, and Software teams to collect design evidence and verification records.

Create and maintain:

Requirements Traceability Matrix (RTM)
Verification & Validation Reports
Risk Analysis Documents (FMEA, Hazard Analysis)
SOPs and Work Instructions
Test Protocols and Test Reports
Clinical Evaluation support documentation
Help establish document control and version management practices (these are still being built out — you'll have input on how they're structured).
Support internal audits and prepare for future external/regulatory audits.
Participate in design reviews and change control activities

What to Expect in This Role

Because this is PlebC's first regulatory hire, you should expect to:

Define and propose processes rather than inherit fully mature ones.
Work closely and directly with the founder/CTO for guidance, escalation, and decisions — not a layer of RA managers.
Have real influence over how TORUS's regulatory pathway is shaped, with the responsibility that comes with that.
Be comfortable with ambiguity in the early months while documentation systems and SOPs are still being established.

Required Qualifications

Bachelor's Degree in: Biomedical Engineering, Electronics & Communication Engineering, Mechanical Engineering, Mechatronics Engineering, Medical Electronics, or related disciplines.
Freshers with strong regulatory coursework or academic projects are encouraged to apply.
Experienced candidates with medical device regulatory experience are equally encouraged — compensation will reflect experience level.

Required Skills

Understanding of the medical device development lifecycle.
Knowledge of mechanical and electronic systems integration.
Familiarity with risk management methodologies (FMEA, Hazard Analysis).
Strong technical documentation and report-writing skills.
Ability to read engineering drawings, schematics, and technical specifications.
Knowledge of quality management systems and document control practices.
Excellent communication and cross-functional collaboration skills — you'll need to work across disciplines without a regulatory team behind you for backup.
Comfort working independently and proactively in a function that's still being defined.

Preferred Skills

Experience with Class B/Class C medical devices.
Exposure to robotic systems, ultrasound devices, or healthcare products.
Familiarity with design controls and regulatory submissions.
Knowledge of cybersecurity and software validation requirements (relevant given TORUS's tele-operated, networked architecture).
Experience with ISO audits and compliance reviews.

Pay: ₹240,000.00 - ₹500,000.00 per year

Ability to commute/relocate:

Gachibowli, Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

Have you worked on ISO 13485 documentation?
Have you prepared DHF, DMR, Risk Management Files, or Technical Files?
Do you have experience with IEC 60601, ISO 14971, or FDA 21 CFR 820?
Have you worked with both electronic and mechanical product documentation?
Describe one medical device or regulated product you have supported from design to documentation — and what your specific role was. (Mandatory, 3-5 sentences)

Work Location: In person

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