Regulatory Affairs Specialist-4 Day Work Week

This job has now expired please search on the home page to find live IT Jobs.

I'm working with a growing medical device company based in Galway. Due to growth plans, a number of positions have opened up in the company to accommodate this and there's a permanent opening for a Regulatory Affairs Specialist on the team. You'll be joining a friendly company who value people that want to learn and grow within the medical device industry long term. This company is located in East Galway which will suit anyone leaving to the east of the city or The Midlands (Athlone is less than 20 mins away). Really accessible location with no traffic. What will I being doing as a Regulatory Affairs Specialist ?Evaluates potential global regulatory pathways for various projects for EU, US and International product launches / product enhancements. Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.Prepares regulatory submissions to regulatory authorities and/or distributors (including the FDA, Notified Bodies, Health Canada and other regulatory authorities).Maintains expertise in worldwide regulatory requirements, with an emphasis on MDR; establishes and maintains positive relationships with regulators.Interacts directly with international regulatory agencies on products / projects at reviewer level. Interacts with various levels of management, external agencies and companies. Works with engineers and technical experts to resolve potential regulatory issues and questions from Regulatory Agencies.Provides support for commercialized products as necessary by reviewing labelling, promotional materials, and product and documentation changes per policy and procedure.Maintains and enhances cross-functional team relationships. Provides technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams.Participates in and assists with Notified Body Audits, MDSAP, FDA facility inspections, and other governmental inspections, as directed.Performs other related duties and tasks, as required.What I need to be a Regulatory Affairs Specialist.An Engineering or Quality Assurance Degree or equivalent experience.A minimum of 6 years within a Medical Device or regulated environment with at least 3 of those years working as a Regulatory Specialist.Demonstrable detailed working knowledge of the medical device industry and the regulatory environment in which the business operates including European (MDD and MDR), FDA, Health Canada, and other International Regulatory requirementsAn analytical approach to problem solvingA good team player, who works well in a small team environment, must be able to work effectively with peers in other departmentsIf you'd like to discuss the chance of becoming Regulatory Affairs Specialist , please send across your current CV and we can have a confidential conversation about this opportunity. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales