Regulatory Affairs Executive to Manager Roles in Delhi

Opportunities in Regulatory Affairs: Executive to Manager Roles in Delhi

Join Clini Experts – Your Trusted Regulatory Partner

Clini Experts, a leading name in the regulatory affairs industry, is thrilled to announce multiple vacancies for Executive, Senior Executive, and Manager roles in Regulatory Affairs at their Delhi and Bengaluru offices. If you have a background in science or engineering and are passionate about regulatory compliance, this is your chance to join a dynamic team dedicated to ensuring the highest standards in the medical device industry.

Open Positions and Qualifications

1. Assistant Manager – Regulatory Affairs (Medical Devices)

Location: Delhi/Bengaluru
Experience: Minimum 7 years in regulatory affairs within the medical device industry
Qualification: Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred

Key Responsibilities:

• Regulatory Knowledge: In-depth knowledge and experience with Indian and international regulations such as EUMDR 2017, MDR 2017, USFDA regulations (including 21 CFR Part 820), and ISO 13485 standards.
• Documentation: Lead the preparation and maintenance of technical documentation, ensuring compliance with EU-MDR 2017 and MDR 2017.
• Submissions: Oversee USFDA submissions, including 510(k), IDEs, and PMAs, and provide strategic regulatory guidance.
• Quality Management: Develop and maintain the QMS in compliance with ISO 13485, managing internal audits, CAPA processes, and training programs.
• Strategic Planning: Formulate global and Indian regulatory strategies considering EU-MDR, USFDA, and other regulations.

2. Executive/Senior Executive – Regulatory Affairs

Location: Delhi
Experience: 1-3 years in regulatory affairs
Qualification: B.Sc./M.Sc. in a scientific discipline, B.Pharm/M.Pharm, or a bachelor’s degree in electronics

Key Responsibilities:

• Project Management: Experience in handling legal metrology and BIS projects.
• Application Filing: Filing and submission of applications for all products under mandatory schemes of BIS, including ISI Scheme (Scheme – I), Foreign Manufacturers Certification Scheme (FMCS), Scheme – IV (Certificate of Conformity), and Compulsory Registration Scheme (CRS- Scheme – II) for Electronics and IT Goods.
• Legal Metrology Compliance: Well-versed with the Legal Metrology Act and Rules and its updates.
• Licensing: Knowledge of model approvals, dealer licenses, repairer licenses, manufacturer licenses, importer registrations, and packer registrations.
• BIS Standards: Thorough understanding of BIS standards, product manuals, Scheme of Inspection and Testing & Grouping Guidelines, and product-specific information.

How to Apply

Interested candidates are encouraged to apply by sending their resumes to the following email addresses:

• Assistant Manager – Regulatory Affairs: contact@cliniexperts.com
• Executive/Senior Executive – Regulatory Affairs: contact@cliniexperts.com