Work Flexibility: Hybrid

Key Areas of Responsibility:

• Develops and implements processes involved with maintaining annual licenses, registrations, and listings
• Reviews and approves advertising and promotion to ensure regulatory compliance
• Assures post-market regulatory requirements are met (e.g. required reports, supplemental submissions and other post-marketing commitments)
• Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
• Participates in implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g. HCP, patient, distributor, and health authorities)
• Reports product safety issues to regulatory authorities as required, to comply with local, regional, and global regulations
• Provides required information in support of product reimbursement requests
• Provides regulatory input and appropriate follow-up for inspections and audits
• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
• Evaluates proposed products for regulatory classification and jurisdiction
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
• Negotiates with regulatory authorities throughout the product lifecycle
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Assists other departments in the development of SOPs to ensure regulatory compliance
• Lead teams to support regulatory processes for market access of products
• Manage budget, if appropriate
• May lead the development of new systems and procedures
• Plans, conducts, and supervises assignments
• Reviews progress and evaluate results
• Support continuous improvement activities
• 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 technical audit/nature

Education / Work Experience:

• BS in a science, engineering or related degree; Advanced degree preferred
• Minimum of 6 years’ experience; 3 years' supervisory experience preferred
• Master's Degree or equivalent preferred; RAC preferred
   

Knowledge / Competencies:

• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
• Demonstrate technical knowledge of medical device, tissues, and/or drug 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
• Ability to understand scientific and health concepts
   

Travel Percentage: None