
Regulatory Affairs
10 hours ago
Profile: Regulatory Affairs (CDSCO)
Location: Paschim Vihar, New Delhi
**Salary**: Up to 50,000
5 Days Working
Exp: 1 to 2 Years
Yearly Bonus
Office Timing: 9:30 to 5:30
**Job Descriptions**:
- Proficient in English.
- Must understand the regulatory requirements for medical devices in India.
- Significant experience within the legislative and regulatory fields applicable to medical devices, including interaction with government officials at India's CDSCO.
- Experience in performing QMS functions to comply with local requirements.
- Able to build and maintain relationships with decision and policy makers within the Taiwan government.
- Excellent knowledge of India's legislative and regulatory landscapes and processes.
- Ability to research and propose well-thought out solutions when dealing with challenges.
- Excellent written, verbal and interpersonal communication skills with demonstrated ability to effectively communicate with company personnel, consultants, and government officials.
- Ability to maintain constructive relationships with individuals at all levels within the organizations and influence without direct authority.
- A strong commitment to excellence and high standards of integrity, professionalism, loyalty, honesty, respect, open mindedness, open communication, respect, and business ethics
- Must be able to work independently, and handle both small and large matters with equal effectiveness and enthusiasm.
- Must be able to thrive in a fast-paced environment with ever-changing business objectives, be willing to adapt to change, as well as being capable of driving change.
**Qualification -**
- Bachelor of Pharmacy (B.Pharm)/Master of Pharmacy (M.Pharm)/M.S Parma, Medical Devices, Pharmaceutics & Drug.
- B.Tech/M.Tech in Biotechnology/Biomedical/Medical Engineering.
- B.E/M.E in Biotechnology/Biomedical/Medical Engineering.
- Statutory and Regulatory Compliance Certificate in Drug Regulatory Affairs (DRA).
- Statutory and Regulatory Compliance Certificate related to Atomic Energy Regulatory Board.
**Salary**: Up to ₹50,000.00 per month
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Delhi, Delhi: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
- CDSCO: 1 year (preferred)
**Speak with the employer**
+91 8076248643
- Health insurance
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