Regulatory Affairs Manager- candidate can come from Quality or Regulatory background.
This is a permanent role with full Stryker benefits- bonus, pension and healthcare for employee and their family.
Key Areas of Responsibility: Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies 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 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 Education / Work Experience: BS in a science, engineering or related Advanced degree preferred Minimum of 8 years experience People Management experience required #IJ #INDEMEA To be considered for this role you will be redirected to and must complete the application process on our careers page.
To start the process, click the Apply button below to Login/Register.