POSITION TITLE: Regulatory Affairs Specialist- India

REPORTS TO: Global RA Manager
LOCATION: Noida, India

PURPOSE OF THE ROLE

The Regulatory Affairs Specialist is a key member of the Quality and Regulatory Affairs team at Global Capability Centre, Noida a Gentell company. The role is responsible for supporting and maintaining compliance of medical devices in accordance with ISO 13485:2016, EU MDR 2017/745, UK MDR 2002 (as amended), FDA Quality System requirements, and MDSAP requirements.

The position supports the preparation, review, maintenance, and control of Technical Documentation pertaining to risk analysis, IFU, Usability engineering, GSPR and regulatory submissions, and compliance activities throughout the product lifecycle. The role works cross-functionally with Regulatory Affairs, Quality Assurance, Manufacturing, and Product Development teams to ensure products and processes remain compliant with applicable regulatory and quality requirements.

KEY RESPONSIBILITIES

1. Risk Analysis

- Ensure compliance with applicable risk management regulations and standards such as International Organization for Standardization ISO 14971, U.S. Food and Drug Administration requirements, and EU MDR and other country specific requirements.
- Prepare, review, and maintain Risk Management Plans and Risk Management Reports.
- Coordinate risk assessments including hazard analysis, FMEA/FMECA, and benefit-risk analysis.
- Evaluate regulatory impact of design, material, manufacturing, supplier, or labelling changes on product risk profile.
- Participate in cross-functional risk review meetings with R&D;, Quality, Manufacturing, Clinical, and Marketing teams.

2. Usability Engineering

- Ensure compliance with usability engineering requirements under International Electrotechnical Commission IEC 62366-1 and applicable regulatory requirements.
- Develop and maintain the Usability Engineering Plan, Identify intended users, use environments, and user interface characteristics.




- Conduct use-related risk analysis and identify potential use errors and hazardous situations.
- Define user needs, intended use, and primary operating functions.
- Support development of user interface specifications and usability requirements.
- Coordinate formative usability evaluations during product development.
- Review labelling, Instructions for Use (IFU) & ensure usability considerations are integrated with Risk Management activities under ISO 14971.

3. Others

- Ensure compliance with applicable microbiological and sterility-related regulatory requirements and standards (ISO 11737, ISO 11135, ISO 11137)
- Review microbiological requirements for medical devices, sterile barrier systems and support development and maintenance of microbiology-related procedures and documentation.
- Coordinate bioburden, sterility, endotoxin, and microbial limit testing activities.
- Support regulatory submissions with microbiological and sterility assurance data.
- Assist in communication with regulatory authorities, Notified Bodies, Authorized Representatives, and external stakeholders as required
- Maintain organized and up-to-date regulatory and quality documentation and records
- Support continuous improvement of regulatory, quality, and documentation processes and systems
- Perform duties as assigned by management.

MINIMUM REQUIREMENTS / QUALIFICATIONS

Education & Experience:

- Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related discipline (or equivalent experience)
- Minimum 2–4 years of experience in Regulatory Affairs, Clinical Affairs, or a combined Regulatory/Clinical role in medical device industry.
- Experience supporting Technical Documentation, Clinical Evaluation, or PMS activities
- Working knowledge of ISO 13485:2016, EU MDR 2017/745, UK MDR 2002 (as amended), and MDSAP requirements.

EEO STATEMENT

We are an Equal Employment Chance Employer and do not discriminate against applicants based on race, age, religion, sex, sexual orientation, gender identity, disability, or any other protected characteristic.

Pay: ₹600,000.00 - ₹1,200,000.00 per year

Work Location: In person

📌 Regulatory Affairs Specialist (India)
🏢 Gentell
📍 India