Regulatory Affairs Specialist-Permanent-Leeds
Recruiter
SidTech
Listed on
25th March 2021
Location
Leeds
Type
Permanent
Start Date
2021-03-25 00:00:00
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Job Title:Regulatory Affairs SpecialistLocation:Leeds, United Kingdom Department/Practice:Life Sciences and HealthcareJob Purpose and primary objectives: The candidate will work with client & TCS teams to deliver best in-class solutions for regulatory submissions, product registrations and product discontinuation of class I, II and III Medical Devices in EU and US. Key responsibilities (please specify if the position is an individual one or part of a team):
The candidate will need to have effective communication skills and be a team player to work with TCS onsite and offshore teams, globally located client cross-functional teams, and external notified bodies/regulatory agencies to execute and deliver as per projects requirements. The candidate will be responsible for the following -Serves as a consultant and technical expert on Regulatory Affairs matters.Under little to no supervision: provides assistance in preparation and submission of global regulatory documents.Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activitiesLeads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.Defines data and information needed for regulatory approvals.Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.Provide Regulatory Affairs support during internal and external audits.Plans schedules for regulatory deliverables on a project and monitors project through completion.Assists in the development of best practices for Regulatory Affairs processes.Represents Regulatory Affairs on cross-functional project teams.Partners with other functions to define and obtain data to assist with regulatory submissions.Be responsible for adherence to timelines in a project environment and ensure project milestones are achieved.Maintain and present self and team matrices to Client and TCS management in structured and timely manner.Report issues to the Client and TCS management to ensure appropriate closure.
Key Skills/Knowledge: Functional and Technical CompetenciesExcellent written, verbal communication and presentation skillsLeverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life- cycle management of products.Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Takes accountability for the achievement of business goals and objectives.Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class II and III devices (EU and USA 510k).Ability to partner and influence key stakeholders on NPD and Lifecycle teams.Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear).Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives.Ability to author and submit US, EU and International Regulatory submissions to Regulatory bodies. Leadership Competencies:Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channelsShape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectivesLead by leveraging div
