Principal Regulatory Affairs Specialist (Remote)
Publication date:
06 October 2024Workload:
100%Contract type:
Unlimited employment- Place of work:Portage
We are currently seeking a Principal Regulatory Affairs Specialist to join our Instruments Division to be based in Portage, MI or remotely anywhere in the United States.
Who we want
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Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
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Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
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Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do
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Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
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Assess links between global, societal, and economic trends; stakeholder concerns and regulatory issues and requirements and the implication for regulatory strategy
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Participates in advocacy activities of a more advanced strategic nature
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Provides guidance to integrate regulatory considerations into global product entry and exit strategy
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Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
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Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes
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Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
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Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
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Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)
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Negotiates with regulatory authorities on complex issues throughout the product lifecycle
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Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
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Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
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Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
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Provides strategic input and technical guidance on global regulatory requirements to product development terms
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Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
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Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
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Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
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Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases
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Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships
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Provides regulatory guidance on strategy for proposed product claims/labeling
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Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
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Manages electronic (eCTD) and paper registration development
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Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions
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Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process
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Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
What you need
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BS Degree in Engineering, Science, or related required
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MS in Regulatory Science or Advanced degree desired
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RAC(s) desired
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Minimum 9 years of experience in medical device regulatory and/or clinical affairs required
$112,800.00 - $239,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.