Manager, Regulatory Affairs - Medical Devices - N Ireland (Permanent)
Manager, Regulatory Affairs - Medical Devices - Northern Ireland
One of the leading global companies specialising in blood and cellular technologies and advancing breakthrough solutions in cell processing, is currently looking to hire a Manager to guide the Regulatory Affairs team to support the launches of new products, maintain regulatory compliance and regulatory systems. The location of the role is in Northern Ireland and they are welcoming relocators!
Responsibilities:
- Develops, or is responsible for the development of regulatory solutions to problems of moderate to intermediate complexity that may affect diverse functional areas of the business or company or unusual complexity in the function
- Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and/or cross functional teams
- Create new methods, techniques and/or processes across job areas or functions exerting some influence on the overall objectives and long-range goals
- Responsible for overseeing regulatory compliance, development and timely national and international regulatory submissions, ensuring that all regulatory activities are conducted with the highest integrity and in an ethical manner
Requirements:
- BSc in Physical/Biological Sciences or Engineering preferred, or similar
- 5 years' experience in Regulatory Affairs
- Experience in gaining FDA or Notified Body approvals for devices or drugs or biologics
- Demonstrated success in the management of regulatory submissions such as CE Mark for Class I-III products, IDE's, IND's, 510(k)'s, NDA's, ANDA's
- PMA experience and/or Regulatory Affairs Certification would be an advantage but not essential
- Fluency in English
If you are interested in this position, don't miss out on this fantastic career opportunity and apply by submitting your CV in WORD version as soon as possible. Alternatively, if you are not available but you know someone that would be interested, share this with them and help people in your network!
Applications are open NOW!
