Himedia Hiring Sr. Executive/Asst. Manager – Regulatory Affairs Jobs

Updated January 28, 2025
Posted in Degree Jobs / Pharmacy Jobs
Tagged as Himedia
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Himedia Hiring Sr. Executive/Asst. Manager – Regulatory Affairs Jobs

Himedia Labs Hiring Regulatory Affairs Professionals in Thane

Himedia Labs, a leading name in life sciences, is seeking experienced professionals for the position of Sr. Executive/Asst. Manager – Regulatory Affairs at their Thane, Wagle Estate location. This is an excellent opportunity for individuals with a strong background in medical device regulations and a passion for ensuring compliance.

Key Responsibilities:

The role encompasses a wide range of regulatory activities, including:

Ensuring Compliance: Maintaining adherence to medical device regulations across various regions.
Device Registrations: Handling device registrations with CDSCO (Central Drugs Standard Control Organization) and international regulatory agencies.
Dossier Preparation: Preparing comprehensive dossiers such as Device Master Files and Technical Files
- Report Generation: Creating essential reports, including post-market surveillance and incident reports.
- License Management: Managing online applications for manufacturing, import, and other licenses through CDSCO and NSWS (National Single Window System).
- Audit Support: Supporting regulatory audits, FDA inspections, and responding to queries from regulatory authorities.
- Training and Documentation: Training staff on regulatory requirements and maintaining accurate documentation.
Required Skills:

The ideal candidate should possess:
- Regulatory Knowledge: Strong understanding of medical device/in-vitro diagnostic devices regulations (both India and international).
- Dossier Expertise: Proficiency in dossier preparation and regulatory submissions.
- Communication Skills: Excellent communication, analytical, and problem-solving skills.
- Technical Proficiency: Competence in compliance software and Microsoft Office Suite.
- Strategic Abilities: Strategic planning and team collaboration skills.
Qualifications:
- Ph.D. with 5-6 years of experience OR MSc. with 9-10 years of experience in Microbiology/Biotechnology PLUS a Diploma or equivalent in regulatory affairs or a related field.
Location: Thane, Wagle Estate

How to Apply:

Interested candidates can visit www.himedialabs.com or share their CV with [email protected].