• Reponsible for international registrations for Arjo products within a designated region
• To ensure that Arjo´s products are compliant to current regulations governed by the Regulatory Affairs Team and that current and future regulations are taken into account in the product development, registration, post market and change management processes.
• To develop, establish and maintain the regulatory strategies for approval of products and ensure regulatory requirements are aligned to achieve rapid market clearance.
• To be a trusted and relailble Regulatory Affairs partner supporting the stakeholders in regulatory functions.
• Prepare product registration documentation for new and amended products licences for medical devices.
• Perform impact assessments on product design, engineering change and management system planning process outputs and updated standards and regulations and prepare action plans to mitigate identified compliance and business risks.
• Communicate progress of registrations with internal and external stakeholders.
• Liase with international affiliates, distributors and competent authorities to ensure timely licence approvals
• Record registration activites on internal tracking databases.
• Prepare briefing summaries and training on regulation, processes and guidelines within area of responsibility.
• Assist in projects within the Regulatory Affairs function.
• Act as internal auditor to established processes and external standards and regulations.
Quality System Duties and Responsiblities:
• Maintain compliance by following assigned Directives, SOPs, Work Instructions in line with current applicable regulations and standards and planned changes.
• Supports management in preparation for internal audits
• Ensures and maintains up-to-date knowledge on domestic and international regulatory requirements, and effectively communicates requirements to management.
• Perform other duties as assigned by Regulatory Affairs Sr. Management.
Each organization shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed and shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
• B.A. or B.S. degree is the minimum requirement with a major in a scientific discipline.
• Considerable regulatory experience in the medical device industry and experience in Quality Assurance / Regulatory Assurance desirable.
• Working knowledge of global medical device regulations.
• Must be able to synthesize technical and clinical information to write clear, understandable licence application documents.
• Must be able to render clear and accurate judgments.
• Ability to work well in cross-functional teams
• Computer knowledge in Microsoft Word, Excel, Access, etc.
• Excellent written and verbal communication skills.
• Intercultural skills
• Ability to work independently in a well-structured and systematic manner
Each organization shall establish the appropriate authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
• Signing documents in the role as regulatory doer in accordance with Arjo QMS
Supervision/Management of Others:
• Not relevant
Internal and External Contacts:
Main contacts, internal:
• TPO, CPO, LQM and documentation engineers in all Arjo manufacturing sites
• Arjo SSU´s
• Employees in global Quality Regulatory Compliance (QRC).
Main contacts, external:
• Distributors, Regulatory agencies / authorities
• The role requires international travel.