Regulatory Affairs

Why Work With Us?
Our products are sold in more than 100 countries.
Our founders have more than 25+ years of combined experience in the medical device industry.
Many prominent IVF Centers use Allwin products.
We aspire to be a worldwide supplier of quality medical devices.
Many of our products are certified by US FDA.
We have CE certification for sale in the whole of Europe.
We are the company that makes all IVF products under roof in INDIA.
Equal Employment Opportunity Policy
Allwin Medical Devices provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Regulatory Affairs

• Designation: Regulatory Affairs
• Experienced: Fresher or 2-5 years
• Qualification: Mechanical Engineer, B.Pharm and M.Pharm
• Location: Mumbai (Kandivali)

  Send us your CV E-mail : [email protected]

• Contact on : +91 93138 07505

Job Description :

• Defines and documents quality management system.
• Implements quality management system throughout the organization
• maintains, and continually improves the effectiveness of the quality system
• Manage validation program
• Manage calibration program
• Maintains and controls quality documents and quality records (i.e., procedures, DHR’s, etc.)
• Coordinates corrective and preventive action process
• Ensures compliance with ISO and Applicable regulatory requirements and Council of European Communities Regulations for medical devices
• Manages customer complaint/feedback system
• Maintains internal and external quality audit records
• Final product disposition
• Quality control function in lab and sterilization area
• Verification and validation of manufacturing processes
• Coordinates & Conducting awareness of applicable regulatory and quality management requirement throughout the organization
• Defining the sequence and interaction between processes
• Conducting management review meeting
• Reporting the performance of a quality system to management for review and provide information for improvement.

Desired candidate profile requirement:

• Proficient communication skills and relationship building skills
• Interpersonal skills
• Computer survey with good knowledge of excel
• Dynamic and hardworking
• Ability to influence and negotiate.
• Hardworking & creative nature.
• Immediate starters

Interested candidates send their resume to[email protected]or fill in the Career form * **Contact on :** +91 93138 07505