Are you an RA Manager/IVDR Regulatory Lead looking for an exciting new opportunity? Do you want to work for a large Medical Device/Pharmaceutical company that make a real difference in the world? Would you be interested in working in an environment where you are valued and offered progression? Are you looking to work in a state-of-the-art facility? If so, this may be the opportunity that you have been searching for…
The responsibilities of the RA Manager will be as follows:
- Regulatory Leadership for the facility for the implementation of the European IVD Regulation.
- Provides training to the IVDR core team employees and other colleagues supporting the IVDR implementation project.
- Coach and mentor cross functional team members to ensure they have a good understanding of the IVDR requirements and apply the knowledge to implement the new processes as required.
- Effectively communicates the progress of the IVDR project within the core team, to the site management team, and to RAQA Senior Leadership.
- Mentor the technical documentation team to lead the workstream to schedule.
- Lead the Notified Body workstream to act as the site contact with the Notified Body.
- Proactively communicate to ensure alignment across all company IVD sites with respect to IVDR.
- Oversee and review Technical Documentation in support of legacy products transitioning to IVDR compliance.
What you will need to do the job:
- Bachelor’s degree in science, medical or technical field. Graduate degree is highly preferred.
- 5 years’ experience within RA and/or QA role at a medical device organisation
- Experience with increasing responsibility in medical device regulatory affairs, ideally IVD.
- Formal training in global medical device Regulatory Affairs. Professional certification through RAPs, or equivalent, is highly desirable.
- Deep understanding of global medical device regulatory requirements and practical experience in implementing or managing such activities (specifically IVDR)
- Related experience includes managing people.
- Experience with in Vitro Diagnostics (IVD)
The successful RA Manager/IVDR Regulatory Lead will be offered the opportunity to join an Organisation that are having an extremely successful period in the industry and you will drive improvement across the facility. Therefore, if you are a Regulatory Affairs professional that is looking for a dynamic, fast-paced environment, who would thrive in an organisation that has a genuine appetite for continuous improvement please get in touch.