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 only company that makes all IVF products under one 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

hr@allwinmedical.com

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 hr@allwinmedical.com or fill in the Career form.

Contact on

+91 93138 07505