Freelance Regulatory Affairs Specialist (ZZP)
Regulatory Affairs Specialist:
Responsible for developing and implementing global regulatory strategy to phase out several product lines.
Create, maintain and execute plans for phase out / phase in of the product lines in line with EU MDR and certificate changes (address and legal entity).
Responsible for the planning, coordination and preparation of document packages for regulatory submissions for released products.
Assure regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews for program teams, provides guidance to the team on risk assessment and required corrective actions to meet regulatory requirements.
As part of the product maintenance and development projects, perform the regulatory affairs activities.
Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways.
The standards for the devices in scope for this role, include Software as a Medical Device (SaMD) and Hardware and Software configurable Devices, Sterilization, IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, IEC 62366, ISO 10993-1, ISO 10993-5, ISO 15223-1, and ISO 20417. Product is targeted at sales worldwide which means medical device regulations following the QMS and in collaboration with counterparts in the target countries.
Special in above is biocompatibility (ISO 10993-1, ISO 10993-5,) and Sterilization.