Regulatory Affairs - Medical Devices @ Citiustech

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Regulatory Affairs - Medical Devices

Citiustech
4 - 9 years
Hyderabad
5 months ago
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Job Description

Key Responsibilities

Provide regulatory strategy and compliance guidance for SaMD and software-intensive medical devices.
Interpret and apply global regulations (FDA, EU MDR, UKCA, Health Canada, etc.) and standards (ISO 13485, IEC 62304, ISO 14971, IEC 82304-1).
Prepare and review regulatory submissions (510(k), CE Technical Files, UKCA documentation).
Support risk management, cybersecurity compliance, and software lifecycle documentation.
Collaborate with engineering teams to align design controls, verification/validation, and usability engineering with regulatory requirements.
Stay updated on evolving regulations for AI/ML-based SaMD and digital health solutions.

Required Skills & Experience

4 to 8 years in regulatory affairs for medical devices, with strong exposure to software and SaMD.
Hands-on experience with IEC 62304, ISO 14971, and cybersecurity standards (e.g., FDA premarket guidance, IEC 81001-5-1).
Proven track record in preparing regulatory submissions for software-based devices.
Familiarity with AI/ML regulatory frameworks and real-world evidence considerations is a plus.
Strong communication skills to interface with global clients and cross-functional teams.

Must Have skill: Regulatory Affairs + SDLC + SaMD

Experience: Minimum 4 years

Location: Chennai/Pune/Bangalore/Hyderabad/Mumbai

Notice: Looking for quick joiners

How to Apply:

Please send your resume to ma********************r@ci*******h.com with the subject line Regulatory Affairs Specialist along with the following details:

Total experience:
Relevant experience in Regulatory Affairs:
Relevant experience in SDLC / SaMD:
Relevant experience in Medical Device:
Current CTC:
Expected CTC:
Notice period:
Current Location:
Preferred location:

Job Classification

Industry: Medical Devices & Equipment
Functional Area / Department: Other
Role Category: Other
Role: Other
Employement Type: Full time

Contact Details:

Company: Citiustech
Location(s): Hyderabad

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Keyskills: Regulatory Affairs Medical Devices Regulatory Compliance SaMD Software Development FDA Mdr medical regulatory

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₹ 10-20 Lacs P.A

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Current / Recent Company (*)

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Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

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Citiustech

Company Website: https://www.citiustech.com/aboutusCitiusTech is a specialist provider of healthcare technology services and solutions to healthcare technology companies, providers, payers and life sciences organizations. With over 4,500+ professionals worldwide, CitiusTech enable...

Regulatory Affairs - Medical Devices @ Citiustech

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