Experience
Salary
Location
Job Description
CTC- 20k-30k
1. Regulatory Compliance:
Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking).
Ensure that products meet all regulatory requirements and maintain relevant documentation.
2. Quality Assurance:
Develop and implement quality assurance processes and procedures.
Conduct internal audits and assessments to identify areas for improvement.
Collaborate with production teams to establish quality control measures.
3. Documentation Management:
Maintain and organize regulatory and quality documentation.
Prepare and submit regulatory filings, such as 510(k) submissions or CE Mark applications.
Create and update technical files and product documentation.
4. Compliance Audits:
Coordinate and participate in regulatory audits and inspections.
Address findings and implement corrective and preventive actions (CAPA) as needed.
5. Risk Management:
Access and manage product risks in accordance with applicable standards.
Develop and maintain risk management files and reports.
6. Cross-Functional Collaboration:
Collaborate with R&D, manufacturing, and clinical teams to ensure alignment with quality and regulatory requirements.
Provide regulatory guidance during product development and changes.
7. Post-Market Surveillance:
Monitor and report adverse events or non-compliance issues.
Educational Qualifications & Experience:
• Bachelor's degree in a Science or B.Pharma/M.Pharma or Biomedical Engineering or Diploma in Regulator Affairs, Quality Management System.
• 3-5 years of experience in Quality Assurance and Regulatory Affairs.
• Knowledge of medical device regulations and quality standards (e.g.- FDA 21 CFR Part 820, ISO 13485)
Designation
QARA
Key Skills
Industry
Medical
Functional Area
Pharmaceutical & Biopharmaceutical
Employment Type
Full Time
Education
Bachelor Degree
Job Type
Work From Office
Related Jobs
Human Resources Generalist
PATENTWIRE CONSULTANTS PRIVATE LIMITED
Join the PATENTWIRE CONSULTANTS PRIVATE LIMITED team as a Full Time Human Resources Generalist on Erekrut, spe...
3-6 Lakhs
1-3 Years
Delhi-New ..
Audit Compli...
Work From Home Opportunity
Work From Home Opportunity
Join the team as a Full Time Recruitment Specialist on Erekrut, specializing in Work from home opportunity in...
0-3 Lakhs
0-1 Years
Delhi-New ..
Audit Compli...
Laravel&Lumen Developer-Re...
Turbotech GBS
Join the team as a Full Time Laravel & Lumen Developer on Erekrut, specializing in Laravel&Lumen Developer-Re...
3-6 Lakhs
1-3 Years
Delhi-New ..
Audit Compli...
Business Development Manager
Passionworkx Infotech
Join the Pllum Legno Pvt. Ltd. team as a Full Time Business Development Manager on Erekrut, specializing in Bu...
6-10 Lakhs
4-6 Years
Delhi-New ..
Audit Compli...
Assistant Interior Designer
Passionworkx Infotech
Join the Passionworkx Infotech team as a Full Time Assistant Interior Designer on Erekrut, specializing in Int...
3-6 Lakhs
1-3 Years
Delhi-New ..
Audit Compli...
Work From Home Opportunity
Work From Home Opportunity
Join the Work From Home team as a Full Time HR Recruiter on Erekrut, specializing in Work from home opportunit...
3-6 Lakhs
0-1 Years
Delhi-New ..
Audit Compli...
Institutional Sales
Erekrut
Join the Erekrut team as a Full Time Institutional Sales on Erekrut, specializing in Institutional Sales in th...
3-6 Lakhs
1-3 Years
Delhi-New ..
Audit Compli...
Sous Chef/Head Chef
Indus Flavour
Join the Indus Flavour team as a Full Time Sous Chef/Head Chef on Erekrut, specializing in Sous Chef/Head Chef...
6-10 Lakhs
11-15 Years
Delhi-New ..
Audit Compli...
