Danaher Corporation RA Manager- IVDR in Newcastle Upon Tyne, United Kingdom
We have an exciting opportunity for an experienced IVDR Regulatory Lead to join our team in Newcastle. In this position you will provide expertise and management of the Regulatory Affairs (RA) function for our cancer in vitro diagnostic reagent business for the implementation of the European IVD Regulation. Responsible for providing Regulatory Leadership for Newcastle for the implementation of the IVDR. Ensures RA results are coordinated across multiple LBS regulatory professionals working in a highly matrixed environment.
In this role, you’ll
Regulatory Leadership for the Newcastle facility for the implementation of the European IVD Regulation .
Provides training to the IVDR core team members and other associates supporting the IVDR implementation project.
Coach and mentor cross functional team members to ensure they have a good understanding of the IVDR requirements and applies the knowledge to implement the new processes as the need arises.
Communicates effectively the progress of the IVDR project within the core team, to the Newcastle site management and site, 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 LBS IVD sites wi th respect to IVDR.
Oversee and review Technical Documentation in support of legacy products transitioning to IVDR compliance
Maintains effective working relationships with LBS global regulatory representatives in a highly matrixed environment, ensuring that all Leica Newcastle products have complete, accurate, timely, and compliant regulatory files.
Stays current on regulatory intelligence and changes that impact the Leica Newcastle business for IVDR implementation. Responsible for developing and implementing changes to local policies and procedures as requirements change.
Effectively use Danaher Business System (DBS) tools to drive continuous improvement.
Responsible for site RAQA IVDR initiatives
Assigned PRRC with the following responsibilities:
Ensuring the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
Ensuring the technical documentation and the EU Declaration of Conformity are drawn up and kept up-to-date;
Ensure the post-market surveillance obligations in Articles 10(9) and 78 are complied with;
All vigilance reporting obligations referenced in Articles 82 to 86 are fulfilled;
Investigational devices contain a signed statement required of Annex XIV Section 4.1 that the device conforms to the general safety and performance requirements apart from the aspects covered by the performance study.
What you’ll need to do the job
Solid 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)
Experience managing people
Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable
Interested? Join the Leica Bio Systems Team!
Want to join our growing team that is helping our customers do incredible work? We look forward to your application!
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.