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Regulatory Affairs Manager EU
This is a divisional role in Micro Biology Division"s (MBD) Global Regulatory Affairs function acting as the European Authorised Representative to the Dutch Competent Authority, Health and Youth Care Inspectorate. The key interfaces for this position would be with Global Regulatory Affairs team, Quality Assurance, Sales and Thermo Fisher regional RA shared services.
Het bedrijf / The company
When you join us at Thermo Fisher Scientific, you"ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Job Title: Regulatory Affairs Manager - EU Authorised Representative
Reports To: International Regulatory Affairs Manager
Job Track: Professional
Position Location: Netherlands-Landsmeer
Number of Direct Reports: 0
Day/Shift (if applicable): N/A
De functie / The role
To carry out responsibilities of the EC REP (European Commission Representative) for MBD"s CE-marked products under the IVD (In Vitro Diagnostics) Directive and IVD Regulation serving as a liaison between MBD and the national Competent Authorities in Europe
Assist with IVD device registrations in EU, as required
Be identified on MBD"s CE-mark product labeling throughout Europe
Provide documentation and products when needed to Competent Authority (CA).
Inform the QA & Vigilance teams in MBD immediately of any complaints and provide leadership or assistance with CAPAs as required
Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with MBD"s distributors
Clearly and proactively communicate any actionable regulatory intelligence in Europe
Establish procedures for all the requirements under the IVD or MD Regulation such as procedures for registration in EUDAMED, verification of manufactures documentation, monitor the compliance of the manufacturer
To actively lead/participate in divisional and functional projects as required related to Subject Matter Expertise
Het profiel / Your profile
Bachelors/Masters Degree, diploma or equivalent combination of qualifications in life science, engineering or legal and related fields.
Proven experience in leadership positions within European regulatory affairs within medical device or IVD industry
Solid Technical knowledge of EU IVD Directive and IVD Regulation or equivalent in Medical Devices Directive/Regulation
Excellent communication and presentation skills to all levels within the organization.
Ability to work efficiently with a large volume of products and modalities
Independent thinking, with a risk-management approach and good collaboration skills
Ability to lead, influence and innovate within a cross-functional environment.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission