Advanced Sterilization Products Hiring for Regulatory Affairs Specialist – MEA Job at Dubai

• Complete all the new product registrations in the area as per company timelines
• Reviews and approves post-market changes, device labeling and marketing materials for compliance with applicable regulations.
• Ensure that all ASP Fortive products are compliant with all other requirements in the area (i.e. Environmental – RoHS, Reach etc.)
• Represents regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion.
• Prepares the responses to regulatory agency inquiries and other correspondence.
• Approve marketing, sales, advertising materials for MEAT
• Support from RA standpoint all documentation for tenders in MEAT
• Completes Fortive Business System Champion training and uses FBS for daily management, KPIs and process improvement

Qualifications

• BS degree (or equivalent) in a related field is required. MS degree is preferred. Additional work experience in lieu of a degree may be considered.
• Arabic language is a must.
• Minimum of 2 years of related work experience in medical device Regulatory Affairs
• Ability to make sound decisions under pressure with reasonable foresight as to outcomes
• Strong collaboration skills and big picture understanding with attention to details
• Knowledge of EU MDD/MDR requirements
• Ability to manage multiple competing priorities effectively
• Strong interpersonal, organizational, negotiation, and problem-solving skills
• Ability to make and execute difficult and often unpopular decisions.

Preferred Skills:

• 2+ years international medical device Regulatory Affairs experience.
• Promotional item and labeling review/approval experience
• Regulatory compliance experience Fortive is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose: to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress. Here, you get the excitement of a “startup” with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth. There’s no limit to what you can learn, or the impact you can make: for you, for us, for growth. Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.