Regulatory Manager Delhi CTC 9LPA
Regulatory Manager Delhi CTC 9LPA
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Job Description
- monitor the changing landscape of medical device regulation updates. This role is responsible for ensuring compliance of ISO 13485/9001 along with medical device regulations.
- Responsibilities
- 1. Developing and executing regulatory strategies and processes for medical device
- products including electronic medical devices.
- 2. Coordinating with team/regulatory authorities to ensure compliance with applicable regulations and standards.
- 3. Analyzing and interpreting applicable regulatory requirements and standards.
- 4. Developing and maintaining regulatory documents such as device master file risk management and product labels design files SOPs etc.
- 5. Performing regular internal audits across corporate offices and factory sites.
- 6. Providing technical guidance to internal and external stakeholders.
- 7. Monitoring and tracking regulatory changes.
- 8. Representing the company at regulatory authority meetings.
- Qualifications
- Knowledge of Indian medical device regulations CDSCO ISO13485 ISO9001 EN
- Standards etc.
- 45 yrs. Experience in regulatory affairs.
- Excellent communication and writing skills.
- Monitoring regulatory requirements and liaising with regulatory authorities.
- Strong background in conducting internal audits and ensuring compliance with regulations.
- Developing and maintaining regulatory strategies.
- Conducting risk assessment and implementation of corrective action plans.
- Preparing and submitting regulatory documents.
- Ensuring compliance with local and international regulatory requirements.
- Providing technical and regulatory advice.
medical device regulations,regulatory affairs,en standards,cdsco,internal audits,compliance,regulatory approvals,iso 13485,risk assessment,corrective action plans,writing skills,regulatory strategies,regulatory requirements,communication skills,iso 9001,regulatory documents
Employment Type
Full Time
Company Industry
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
