Job closed
Ref: OP244-10
Job description / Role
Position Objective:
Regulatory Affairs Officer acts as a link between Company and the regulatory authorities, ensuring that the products that are distributed by Maquet Middle East are in compliance with the appropriate legislation.
Essential Duties and Responsibilities:
Manage and facilitate all medical devices related registration activities for Middle East and Africa Region.
Complete forms and requests originating from government agencies.
Maintain contact with regulatory authorities and company headquarters in Germany.
Provide the Project teams and Managers with regulatory input in order to obtain timely regulatory approvals for the products (medical devices) as part of the product development planning.
Assure compliance with Export regulation for US manufactured products (OFAC & BIS).
Update licensing and collect information on registration instructions and regulations.
Requirements
Qualification (Knowledge, Skills and Abilities):
Life Sciences Degree or equivalent.
At least two years of experience in managing Regulatory Affairs either locally or internationally for Middle East and Africa region.
Must be an Arabic Speaker (English and Arabic is must).
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.