What you will do

• Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies

• Assess links between global, societal, and economic trends; stakeholder concerns and regulatory issues and requirements and the implication for regulatory strategy

• Participates in advocacy activities of a more advanced strategic nature  

• Provides guidance to integrate regulatory considerations into global product entry and exit strategy

• Identifies regulatory pathways for initial product designs and provides input to internal stakeholders

• Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes

• 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

• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations

• 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)

• Negotiates with regulatory authorities on complex issues throughout the product lifecycle

• Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution

• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures

• Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

• Provides strategic input and technical guidance on global regulatory requirements to product development terms

• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions

• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions

• Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans

• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases

• Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships

• Provides regulatory guidance on strategy for proposed product claims/labeling

• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims

• Manages electronic (eCTD) and paper registration development

• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions

• Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process

• Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees

What you need

• BS Degree in Engineering, Science, or related required

• MS in Regulatory Science or Advanced degree desired

• RAC(s) desired

• 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.