Amsterdam, Noord-Holland, NetherlandsQuality
The Medical Device Regulatory Specialist is responsible for ensuring that medical devices comply with relevant regulatory requirements, standards, and guidelines. They ensure that products are safe and effective for patient use and that the Pacmed's claims are supported by adequate testing and clinical data. The Specialist also ensures that Pacmed is compliant with relevant regulations, currently MDR in the EU, and in the future, other markets.
Work with cross-functional teams to ensure regulatory compliance throughout the product lifecycle, including design control, risk management, clinical evaluation, and labeling
Prepare and maintain regulatory documentation and technical files, and submit to regulatory authorities
Review and interpret regulatory requirements and guidelines for medical devices
Develop and maintain regulatory strategies and plans for product development and approval
Monitor and assess changes in regulatory requirements and communicate them to relevant stakeholders
Represent the company in interactions with regulatory authorities, such as pre-submission meetings, advisory committees, and audits
Bachelor’s or Master’s degree in life sciences or engineering with an affinity for technology and AI
3+ years of experience in medical device regulatory affairs within Medtech
Knowledge of regulatory requirements and guidelines, such as MDR and other horizontal standards such as IEC 62304, IEC 62366, ISO 14155, ISO 14971, and ISO 15223-1
Familiarity with regulatory submission requirements and processes
Experience in conducting regulatory assessments and gap analyses
Strong written and verbal communication skills, including the ability to communicate complex regulatory concepts to non-regulatory stakeholders
Attention to detail and ability to work independently and in a team environment.
Energetic and hands-on team player who likes to work in an international, cross-functional environment within a young and growing company