SUMMARY OF POSITION:
The Regulatory Affairs Leader (EMEA) will be responsible for leading current and future regulatory filings (i.e., input, direction, resolution) in the EMEA region and will serve as our clients liaison for the local Governmental bodies.
· Study and understand local/international regulations, provide basic suggestion on registration or certification
· Monitor the whole registration process to gain product registration certificates to ensure fulfill product registration plan
· Ensure compliance with EMEA regulatory requirements
· Provide input and direction for EMEA registration priorities
· Establish and maintain good relationship with key contacts
· Provide active and strong regulatory supports to internal departments, as needed
· Participate in internal and external government product audits by various regulatory agencies
· Recommend strategies for earliest possible approvals and clinical trials applications
· Quality Assurance (QA) input for maintenance of Quality Management System elements specific to EMEA
· BA/BSc in science field required. MA/MSc is an advantage.
· At least 5 years working experiences in medical device regulatory affairs.
· Experience with IVD products' standards and filings
· Familiar with medical device registration process, regulations and standards
· Process-driven, carefulness, preciseness and supportive, attention to detail
· Good interpersonal communication skills
· Excellence with Microsoft Office Suite
· Excellent verbal and written communication in English
Any applicant must have an existing work permit/ visa for Ireland to apply. (Stamp 4 or EU passport)