Integrum is marketing the OPRA Implant System, a bone-anchored system based on osseointegration, where the prostheses are directly attached to the bone, thereby avoiding the use of a socket. The system is clinically well tested and, since 1990, it has helped more than 400 individuals to improve their quality of life. The company is headquartered in Gothenburg and is currently looking for a QA/RA Director to join the management team. You will be responsible for the QMS and as well as Quality Assurance and Regulatory Affairs. Responsibilities include but is not limited to:
-Ensure that the QMS is applicable, effective and up to date with regulatory requirements
-Official Contact with regulatory authorities
-Regulatory Affairs responsible in projects developing new products, line extensions and upgrades according to product launch plan
-Develoop and maintain Company regulatory strategy
-Plan and perform regulatory submissions and updates worldwide to achive market access (e.g. CE-marking, PMA, 510K, HDE, IDE, Annual reports)
-Coordinate certification audits and regulatory GMP inspections
-Plan and perform internal audits as well as supplier audits
-Management representative – planning and leading management Reviews
-Accountable for risk management procedure
Suitable candidates have experience from the medtech industry, working with similar tasks and previous experience with FDA. A background from both small and large organisations is preferred. You thrive in a small organisation with a broad range of responsibilities.
Please contact Daniel Kremer for questions or send your CV to firstname.lastname@example.org!