Job closed
Ref: OP244-26
Job description / Role
Position Objective:
Regulatory and Quality Affairs Specialist acts as a link between Company and regulatory and quality affairs authorities, ensuring that the products that are distributed by Getinge Group Middle East are in compliance with the appropriate legislation and quality standards.
Essential Duties and Responsibilities:
• Manage and facilitate all registration related activities.
• Complete forms and requests originating from government agencies.
• Maintain contact with regulatory authorities and company headquarters.
• Provide the Project teams and Managers with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.
• Assure compliance with Export regulation for US manufactured products (OFAC & BIS).
• Distribute and follow up Field Safety Actions.
• Deal with quality related questions and complaints.
• Update licensing and collect information on registration instructions and regulations.
• Serve as a point of contact and handle all quality assurance related issues such as recalls, safety notices….etc.
• Ensure a high level of internal and external customer service. Investigate (and correct) customer issues and complaints relating to quality
• Analyze facts or circumstances surrounding quality problems to determine what action should be taken and set and manage a corrective action plan.
• Develop, execute, and continually improve a comprehensive quality program
• Lead and manage the entire range of quality programs
Requirements
• Life sciences degree or equivalent, preference shall to be to Medical Devices or Pharma field
• Minimum 3 - 5 years of experience in Regulatory and Quality Affairs
• Excellent verbal and written communication skills.
• Excellent organization skills.
• Excellent time management skills.
• Careful planning to achieve accurate and timely results.
• Work precisely according to procedures, rules and regulations.
• Recognize recurring issues and analyze their causes in order to reach a solution.
• Self-motivated.
About the Company
Getinge Group is a leading global provider of innovative solutions for operating rooms, intensive-care units, hospital wards, sterilization departments, elderly care and for life science companies and institutions. With a genuine passion for life, we build quality and safety into every system.
Our unique value proposition mirrors the continuum of care, enhancing efficiency throughout the clinical pathway. Based on our first-hand experience and close partnerships, we are able to exceed expectations from customers – improving the every-day life for people, today and tomorrow.