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.

RESPONSIBILITIES

• 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.