Senior Regulatory Affairs Specialist – Medical Devices
Pplus Skin Care Limited
This is a fantastic opportunity for a highly experienced and driven individual to join a fast growing, exciting and highly innovative medical device company. As a key member of the company’s technical team, you will apply your passion for excellence and detail to the role making a critical impact on our next growth journey.
Pplus Skin Care Limited has developed a patented and unique skin product which, is a breakthrough in the field of Regenerative Medicine. Developed based on Platelet-Rich Plasma (PRP) technology, Pplus products are medical devices and fit in 2 global, multi-billion-dollar Wound Care and Cosmetic, markets. You will be a part of a team working in a highly regulated fast paced environment to aid the transition of a proven concept design into manufacturable medical device that meets all regulatory requirements for a successful commercial launch. The role will allow you to take a hands-on approach to lead the international regulatory compliance function of the business.
· Work with internal and external stakeholders to support in the design and development process and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development lifecycle.
· Continuously drive regulatory activities in strategic markets to ensure timely product approvals and actively support improvement initiatives.
· Participate in external audits and liaise with notified bodies/competent authorities to obtain and maintain product approval.
· Support the Development, management, and maintenance of the company’s device technical files.
· Develop and maintain an excellent understanding of the company’s procedures and products.
· Keep up to date with changes in regulatory legislation and guidelines in markets that the product is going to be launched.
· Assist in the interpretation of standards and testing of the devices and communication with relevant test houses.
· Assist the QA Team in the implementation and maintenance of the company’s ISO 13485:2016 Quality Management System.
· Ensure timescales and regulatory pathways are fully understood and work closely with the team to meet the scheduled Project plans.
· Working knowledge of ISO13485:2016, ISO14971:2019, MDD93/42/EEC and EU MDR 2017/745 and other relevant standards is essential
· Experience of producing technical documentation for medical devices.
· Exposure within Ireland regulatory framework with potential for involvement in EU procedures.
· Good attention to detail, be able to demonstrate excellent record keeping, organisational and planning skills.
· Minimum 8 years’ experience of working in a QA/RA role within medical devices.
Must be an Irish resident.