Work Flexibility: Hybrid

Regulatory Affairs Manager

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
Manage day-to-day regulatory processes to ensure issues are appropriately evaluated
Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement
Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met
Serve as Subject Matter Expert for regulatory processes
Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations
Establish standard process to ensure appropriate resolution and management of the responsible task owner
Chair meetings required to drive closure of regulatory issues
Manage and provide updates for regulatory metrics. Implement appropriate enhancements
Represent regulatory processes during internal and external audits
Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets
Recruit, select, and on-board top talent
Develop talent within team to increase performance. Actively address performance issues on team
Maintain a high level of team engagement
Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature
Establish annual budgets and quarterly forecasts
Make necessary changes with appropriate management involvement

Education / Work Experience:

BS in a science, engineering or related Advanced degree preferred
Minimum of 8 years experience
Master's Degree or equivalent preferred
RAC Desired
People Management experience required

Knowledge / competencies

Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
Demonstrate technical knowledge of medical device product lines
Demonstrated written, verbal, listening, communication, and team-building skills
Demonstrated ability to collaborate effectively with and lead cross-functional teams
Demonstrated ability to effectively prioritize and manage multiple project workloads
Demonstrated experience with trending and analysis reporting
Demonstrated leadership skills
Demonstrated process improvement and management skills
Experience with recruiting, people development
Influence across the organization

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Travel Percentage: 20%

Regulatory Affairs Manager

Job Description