Cyber Security Specialist in healthcare domain

Job Title: Cybersecurity expert in Healthcare domain
Relevant Experience Require: 5+ Years
Location: Bangalore/Coimbatore

Work mode: Work form office only

Total Vacancies: 3

5y to 6 y 1 vacancy

7y to 8 y – 1 vacancy

9y -10 y - 1 vacancy

Notice period – 30 days max.

Key Responsibilities:

1. Medical Device Experience (5+ Years):

• A minimum 5 years of direct, hands-on experience in medical device cybersecurity, preferably a Class III device.
• Have demonstrated experience in creating documentation for at last one FDA 510K, PMA submission, or EU MDR technical documentation submission.
• Hands-on experience with standards like ISO 14971, IEC 62304 and ISO 13485 and experience in aligning these with regulatory requirements.
• Proven track record of working on devices with Bluetooth communication, mobile apps, and cloud integration.

2. Regulatory Documentation Expertise:

• In-depth knowledge of FDA submission requirements, including: Cybersecurity documentation for 510(k) and PMA submissions, Creation of threat models, risk management files, and security testing reports tailored to FDA guidance.
• Familiarity with CE marking requirements for the EU, including: Cybersecurity sections for Technical Documentation under MDR, Ensuring compliance with ISO 14971, IEC 62304, and IEC/TR 60601-4-5.
• Demonstrated ability to produce submission-ready documentation in formats acceptable to both the FDA and Notified Bodies.

3. SDLC Integration:

• Expertise in integrating threat and vulnerability management across the Software Development Lifecycle (SDLC).
• Ability to trace threats, risks, and mitigations through design, development, and testing stages, ensuring that all necessary artifacts are prepared and submission-ready for the specific Notified Body.

4. Cybersecurity Risk Management:

• Experience in conducting and documenting:
• Threat modeling (e.g., STRIDE), Risk assessments and alignments with AAMI TIR57 and ISO 14971.
• Security testing results, including penetration testing and vulnerability assessments, documented in submission-ready formats.

5. Standards and Compliance:

• Familiarity with relevant standards for medical device cybersecurity:
• FDA Premarket Guidance for cybersecurity risk management, ISO 13485 for quality system integration and IEC 62304 for secure software lifecycle processes.

6. Communication and Collaboration:

• Strong ability to work cross-functionally with engineering, regulatory, and quality teams to ensure submission documentation meets all regulatory requirements.

Experience presenting and defending cybersecurity strategies and documentation during audits or regulatory reviews.