Thermo Fisher is seeking an experienced Regulatory Affairs professional to join the exciting area of In Vitro Diagnostic and Clinical Research products.
The position is located on one of our IVD manufacturing site in Europe, or home-based, reporting to Manager of Regulatory Affairs and will work in the Global Regulatory Affairs department with members from Global Quality Assurance, and several Global Customer Facing Teams to evaluate and execute complaint handling, adverse event reporting, and recall strategies that are compliant to global regulatory requirements, specifically affecting IVDs on EMEA markets.
You will be responsible for managing the field action/recall process for EMEA region and ensuring global regulatory authorities are notified within the appropriate time restrictions.
In addition, you will conduct global training for regulatory compliance, maintain key MDR/recall performance metrics, participate in process improvement projects, and assist with audits.
You will have the opportunity to interact with Thermo Fisher Scientific colleagues all over the world and have the ability to influence organization’s global policies and procedures to improve regulatory compliance.
Title is dependent upon experience.
What will you do?
Serve as a member of the Global Regulatory Affairs department and will have direct line reporting to IVDR RA Manager and supporting EMEA Director of Regulatory Affairs/Clinical.
Act as subject matter expert regarding customer complaint processing, adverse event reporting, and, field action, and recall reporting.
Independently lead others and conduct regulatory assessments with minimal guidance or supervision.
Determine global product field action and recall strategies.
Apply knowledge of device regulatory requirements in order to complete and submit MDR/AE reports and recall reports within regulatory timeframes.
Manage field action strategies and associated regulatory body notifications.
Maintain, develop, and modify global procedures for regulatory reporting decision models regarding recalls and MDR/AE to uphold compliance with reporting regulations.
Author and peer review global regulatory field action and MDR/AE reports to ensure on-time submissions to the appropriate regulatory authorities.
Author Health Hazard Evaluations and work with medical experts to determine potential health risks in the field.
Coordinate with Global Regulatory Affairs team members in APAC, EU, LATAM, and Americas regions to ensure customer complaint and nonconforming product data is properly analyzed and regional health authority reporting decisions are documented adequately.
Ensure continued compliance with ISO 13485 and global regulatory requirements incl.Therapeutic Goods Administration, Medicines and Healthcare products Regulatory Agency, and other applicable regions.
Generate key recalls / MDR metrics and status reports for Leadership and corporate review.
Participate in process improvement projects.
Responsible for SOP revisions/document creation/annual document review as assigned.
Review customer notifications.
Interface with Quality Assurance and Customer Facing Teams for product investigations and trend reporting.
How will you get here?
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science without relevant direct experience.
Must have a minimum of 3 years of IVD Regulatory Affairs experience.
Experience with complaint handling and recall reporting is highly desirable.
Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
Direct and positive experience in communicating with Regulatory Authorities and internal partners.
Demonstrate in-depth understanding of technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
Capacity to communicate regulations to technical functions within the company
High energy level; positive attitude; detailed oriented; works well under stress
Hands-on, action-oriented, and able to implement effectively through his/her team
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Able to work autonomously in a matrix-managed organization
Ability to provide solutions based on knowledge of regulation and industry experience
Willingness to travel (~10-15%)
Comfortable with ambiguity and change
Comfortable working within colleagues in different regions under tight timelines
Excellent knowledge-based PC computer skills essential
Understanding of medical terminology
Experience in regulated environment and pertinent to ISO 13485 is preferred.