Thermo Fisher Scientific is looking for an experienced Regulatory Affairs professional to join the exciting area of In Vitro Diagnostic and Clinical Research products.
The position is located in one of our sites in Europe or home based, reporting to the Manager Regulatory Affairs, Post Market and Vigilance.
If you are passionate about working in an organization that allows you to make decisions and have an impact towards our customers, for the patients and the community, Thermo Fisher Scientific is the place for you.
What will you do?
In this exciting role as a Regulatory Affairs Specialist, you will join an internationally diverse and very supporting Global Regulatory Affairs team, working closely with several departments and legal manufacturers around the world, such as R&D, Quality Assurance, Product Managements, providing guidance and interpretation regarding the transition from the current Directive 98/79/EC to the In Vitro Diagnostic Regulation, 2017/746.
In this role you will have the opportunity to influence organization's global policies and procedures to improve regulatory compliance.
In addition, you will be responsible for managing the field actions/recalls and adverse events reporting for the EMEA region, ensuring that local Competent Authorities are notified on time as required by the applicable legislation as well as providing updates on open Vigilance cases.
- Maintain a thorough and up-to-date knowledge of regulatory requirements, applicable standards and post-market requirements throughout the product lifecycle and communicate upcoming changes, in a timely manner, to the internal teams.
- Ensure regulatory requirements related to post-market and vigilance are incorporated in our internal Standard Operating Procedures (SOPs) and Work Instructions.
- Review the customer complaints and assess whether they need to be reported to the local Competent Authority, on time, as adverse events and/or Field Actions.
- Collaborate with R&D, Quality Assurance and Product Managers to file the reportable events to the related Competent Authority.
- Manage and drive all queries received from Competent Authorities, Notified Bodies and internal stakeholders in regard to any post-market activities related matter.
- Independently lead others and conduct regulatory assessments with minimal guidance or supervision.
- Review and contribute to Health Hazard Evaluations (HHE) / Field Safety Notices and work with medical experts to determine potential health risks for the products already in the field.
- Ensure continuous compliance with ISO 13485 and ISO 14971 in order to maintain an excellent level of vigilance for the assigned products portfolio.
- Participate in process improvement projects.
- Driving Regulatory intelligence by participating in recurrent meetings with MedTech Europe and Medical Device Coordination Group (MDCG).
Skills, Knowledge and Experience required
- Bachelor's or Master's degree in a technical field such as Biology, Engineering, Physics or Chemistry.
- Minimum of 2 years of Regulatory experience in IVDs and/or medical devices.
- Demonstrated experience in creating or reviewing adverse events and Field Safety Corrective Actions reports.
- Ability to provide solutions based on knowledge of regulations and IVD industry.
- Experience with Notified Body audits under ISO 13485 is highly preferred.
- Working knowledge of In Vitro Diagnostic Directive (98/79/EC) as well as an understanding of the requirements of In Vitro Diagnostic Regulation (2017/746) is highly preferred.
- Able to interpret regulations and guidance documents in order to maintain compliance within the EMEA region.
- Able to work autonomously in a matrix-managed organization.
- An excellent level of English is a must and knowledge of other languages is a plus.
- Willingness to travel internationally occasionally
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