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EU Sr Regulatory Affairs Specialist/ Manager


When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.Location/Division Specific InformationWarrington (KG), Cheshire, Great BritainHow will you make an impact?Thermo Fisher is seeking an experienced Regulatory Affairs professional to join the exciting area of molecular diagnostic products. Main area of focus is leading covid-19 and enable clinical market penetration regulatory effort.This position will provide strategic and tactical support to In-Vitro Diagnostic core teams and can be located in Warrington (KG), Cheshire, Great Britain.The position will work in the Global Regulatory Affairs department and will establish and execute the regulatory strategies, lead EU-IVDD, IVDR, Notified Body and Competent Authority submission, and other European registration activities.This Regulatory Affairs professional will support the COVID-19 business through utilization of our PCR or other relevant technologies.Title is dependent upon experience.What will you do? Responsible for providing guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various European regulations and coordinates regulatory issue resolution through the use of internal resources, Notified Bodies, and outside consultants as needed.The delivery of regulatory guidance to project teams and external partners are key activities toward assisting the Company in achieving its business goals. Incumbent will serve as a member of the Global Regulatory department and will have direct line reporting to Sr. Manager of Regulatory Affairs.Serve as the European regulatory lead for Genetic Solution Testing (GTS) group and provide active and ongoing regulatory guidance to project teamsDocument regulatory strategies for product submissions.Lead and prepare EU regulatory submissions including but not limited to CE-IVDD and CE-IVDR technical files, competent authority submission, clinical trial applications (CTA) for COVID-19 and/or PCR assaysFacilitate Notified Body and competent authority consultation meetingsCoordinate GTS business clinical trial activities in EuropeInteract with European commercial team for GTS European regulatory activities and participate in business meetings with potential new external partnersFacilitate global CE regulatory registration representatives for product global registration activitiesPerform regulatory assessment of new and changed products.Responsible for providing regulatory compliance support for both regulated and non-regulated IVD products to the Responsible for providing regulatory compliance support for both regulated and non-regulated IVD products to the Warrington facility.Facilitate GTS Europe complaint assessment to determine adverse event reporting, if applicable.Review advertising and promotional materials against European policies and external guidance/regulationsKeep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.How will you get here?A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.Experience:Must have a minimum of 4 years of Medical Device and/or IVD Regulatory Affairs experience.This experience must include either CE-MDD, CE-MDR, CE-IVDD, or CE-IVDR submissionMust be well versed in the aspects of European regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.Experience as the RA representative on project teams providing active and successful regulatory guidance and RA strategies.Experience in the balance and application of regulatory requirementsDirect and positive experience in communicating with Regulatory Authorities and co-development partners.Regulatory review of promotional marketing materials, press releases, labeling, etc.Demonstrate in-depth understanding of advanced 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 companyRequired Qualifications:High energy level; positive attitude; works well under stress, Strong communicator and leaderHands-on, action-oriented, and able to implement effectively through his/her teamContinuous improvement minded; familiar with balancing the need for Quality and the need for efficiencyAble to work autonomously in a matrix-managed organizationAbility to provide solutions based on knowledge of regulation and industry experienceWillingness to travel (~10-15%)Comfortable with ambiguity and chang*GTSDoubleAt Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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Warrington, England, Warrington, WA1, United Kingdom

  • Ad ID:  16709209
  • Ad Type:  Offered
  • Posted on:  13/11/2020, 03:11
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