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.
POSITION DUTIES & RESPONSIBILITIES:
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 activities
Leads 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.
Functional and Technical Competencies:
Excellent written, verbal communication and presentation skills
Leverages 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).
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.
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 channels
Shape 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 perspectives
Lead by leveraging diverse perspectives and backgrounds to generate effective ideas or solutions
Deliver by acting with speed, flexibility , accountability and appropriately managing priorities to deliver results for on-time clearances
EDUCATION & EXPERIENCE REQUIREMENTS:
BS with minimum 6 years of experience or equivalent
Practical experience with the preparation and submissions for Class II and III medical devices ( EU and USA)
Substantial experience of US, EU and International Regulations required. Knowledge of International Regulations in China, Japan, Brazil and Russia preferred.
Knowledge of Additive manufacturing technology and associated regulations ( Software), advantageous.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
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