At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
TE Connectivity is a $13 billion global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With nearly 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn , Facebook , WeChat and Twitter .
Creganna Medical is ranked among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 companies across 30 countries, Creganna Medical’s customers include the world’s leading medical device and life science companies. Headquartered in Galway, Ireland, Creganna Medical has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia. http://www.creganna.com/
The primary function of this role is to supervise the Regulatory Affairs area to ensure that it runs in a smooth and efficient manner. The function will involve a thorough understanding of both the regulatory requirements required for the Medical Device Industry. The role will report directly to Snr Manager of Regulatory Affairs
Responsible for supervising the day to day workload and operational issues of the regulatory affairs team. This includes, but is not limited to, setting team and individual objectives, carrying out performance appraisals, generating training plans and dealing with performance-related issues.
Co-ordinate the day to day running of the regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
Maintains an excellent understanding of the global medical device regulations.
Actively pursues ways in which to improve the function of the Regulatory Affairs Department.
Ensure compliance to 21 CFR 820, ISO 13485, MDD, MDR, MDSAP, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Provides regulatory leadership to development teams e.g. cross-functional alignment with issues of possible regulatory ramifications.
Acts as a liaison with Quality, R&D, Legal, and Operations.
Prepares submissions for device design changes and /or manufacturing changes.
Reviews product and manufacturing changes for compliance with applicable regulations.
Reviews protocols and reports to support regulatory compliance and submissions.
Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body)
Uses project management experience to create timelines and provide deliverables for regulatory projects.
Provides guidance to management on upcoming regulatory changes (Brexit, MDR,) and the impact of those changes.