Regulatory Affairs Manager - Medical Device & Pharma

Job Title: Regulatory Affairs Manager - Medical Device & Pharma

Location: Rohini, Sector-3, Delhi

Company: ELT Corporate Private Limited

About Us:

ELT Corporate Private Limited is potentially growing regulatory affairs company dealing primarily in medical device and cosmetics regulatory space and aspiring to expand its operations in Pharma Space.

Job Summary:

The Regulatory Affairs Manager is responsible for ensuring the company's compliance with all applicable regulations related to the development, manufacturing, and distribution of medical device and/or pharmaceutical products. This role involves developing and implementing regulatory strategies, preparing and submitting regulatory submissions, and interacting with regulatory agencies to secure and maintain product approvals.

Responsibilities:

• Knowledge of CDSCO regulatory of Medical Devices and preference shall be given if having knowledge in pharma regulatory.
• Knowledge of USFDA, EU CE for medical devices.
• Manage the preparation, compilation, and submission of regulatory documents.
• Training of fresher in Medical Device and Pharma Regulatory.
• Knowledge of other regulations impacting medical device industry like AERB, NPPA, Legal Metrology, BIS.
• Knowledge of GMP, ISO 13485 and Other ISO related to medical device and Pharma industry.
• Participate in internal and external audits to ensure compliance with regulatory requirements.
• Develop and implement standard operating procedures (SOPs) related to regulatory affairs.
• Manage post-market surveillance activities, including adverse event reporting.

Qualifications:

• Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Engineering) oa related field. Advanced degree preferred.
• 5-10 years of experience in regulatory affairs within the medical device and/or pharmaceutical industry.
• In-depth knowledge of relevant regulations, including FDA regulations (21 CFR), EU MDR/IVDR, and other applicable global regulations.
• Proven experience in preparing and submitting regulatory submissions.
• Strong understanding of product development processes, quality systems (e.g., ISO 13485), and GMP requirements.
• Excellent communication, writing, and interpersonal skills.
• ∙Strong analytical and problem-solving skills.
• ∙Ability to work independently and as part of a team.
• ∙Proficiency in regulatory information management systems.
• ∙RAC (Regulatory Affairs Certification) preferred.

Job Types: Full-time, Permanent

Pay: ₹22,000.00 - ₹100,000.00 per month