The Regulatory Specialist is a part of the Process Management team in Research & Development (R&D) and works
closely with cross functional groups in various R&D locations to ensure regulatory compliance throughout the product
development lifecycle of Össur‘s medical devices.
• General adviser for the regulatory and normative landscape relevant to the design and development activities;
• Guide and coach product development teams on applicability of regulatory requirements throughout
• Advise development teams on the establishment and maintenance of product technical files;
• Contribute as a regulatory expert to the development and maintenance of internal R&D processes;
• Participate actively to design review as regulatory adviser;
• Review and approve documents forming the product technical files;
• Participate in internal and external audits and inspections;
• Support preparation of submissions and technical dossiers for market registration and clearance activities;
• Monitor relevant regulations and standards applicable to design and development activities of medical devices.
QUALIFICATIONS & SKILLS
• University Degree in Engineering, Life Sciences or similar;
• 3 to 5 years minimum work experience in the medical device industry;
• Preferred 1 – 3 years as direct contributor and collaborator in medical device development;
• Working knowledge of ISO 13485, FDA Title 21 CFR Part 820, Medical Devices Regulations (EU) and ISO 14971;
• Preferred knowledge of IEC 62304, IEC 62366 and IEC 60601-1.
• Demonstrated effectiveness at communicating (oral and written, especially English) and influencing across functional, technical and organizational boundaries;
• Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks;
• Strong leadership and teamwork skills.
Application period ends July 15th, 2019.
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