Regulatory and Compliance Specialist - EU

ObjectiveTo provide regulatory compliance and submission support to Global GID and production sites with focus in EU. To support continued growth of regulatory services offerings and customer requirements.

LocationPreferably Denmark or Ireland, but can be located anywhere in Europe

Business UnitManufacturing

DepartmentMedical

Key Responsibilities

• Act as core team member of RA/QA for project development life cycle.
• Maintain Country and Regional License renewals and annual registrations.
• Interpret existing and/or new regulatory requirements as they relate to products and procedures and communicate this to personnel.
• Responsible for creating Clinical Evaluation Reports as needed.
• Coordinate with Notified Bodies, Competent Authorities and other regulatory agencies on submissions, audits, approvals or other issues
• Ensure information relevant is available to customer submissions via Drug Master Files (DMF) or Device Master Files (MAF)
• Research, author or otherwise provide support in preparation for and updates to Technical Files
• Review and approve marketing/training materials.
• Develops regulatory strategy for difficult issues which could significantly impact project timelines and costs
• Development, implementation and maintenance of regulatory SOP’s and development/improvement of processes and procedures
• Ensures compliance with applicable national and international regulations and standards during all phases of the product life cycle.
• Performs compliance auditing activities to ensure on going status of sites.
• Directs the development and implementation of systems for regulatory service offerings which meet regulatory requirements to ensure timely product approval and maximize market opportunities.
• Assists in regulatory inspections and corrective actions
• Drives GLSS (Global Lean Six Sigma) initiatives in for enhancing safety, compliance, operational efficiencies and cost savings.
• Supports and drives amongst the Teams, MBM principals.
• Supports development and launch of myQMS Global Quality Management System
• Other duties as assigned
• Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction
• Regional EU travel and occasional global travel may be required – 15%

Education / Experience

• Minimum 5 years’ experience in regulatory affairs within the Medical Device/Pharma industry
• BS/BA in science, engineering, business, quality/regulatory degree
• Masters or industry qualification in Regulatory Affairs desirable.
• Knowledge of applicable international regulations and standards (CFR, MDD/MDR, QSR, ISO 13485, CMDCAS, etc.) preferred
• Good knowledge of product development and processes
• Experience with regulatory audits and inspections
• Microsoft Word and Excel proficiency
• Technical report writing skills
• Demonstrated attention to detail
• Ability to work independently or in a team environment
• Excellent written and verbal communication
• Strong organizational and analytical skills
• Ability to partner effectively with peers
• Strong and effective communication skills, including verbal, written, presentation and negotiation
• Catalyst for change
• Proven experience in handling submissions in major markets (US/EU/Japan)
• Experience in creating the optimal regulatory approval pathway in development project

Required Skills / Competencies

• Leadership skills including ability to maintain confidentiality
• Decision making and prioritization skills
• Strong written, verbal and interpersonal communication skills with the ability to influence outcomes
• Strong organizational skills with high attention to detail
• Excellent team player, with ability to get along with colleagues and work as part of a team
• Problem solving skills
• Flexible attitude to work - ability to adapt to changing demands and requirements
• High level of written and verbal communication in English

How to apply

Applications for the position shall be sent to Bryan Moris, Director of Global Pre-Production Quality: [email protected]


Kilde: Jobnet.dk