Staff RA Specialist in Carrigtohill at Stryker Corporation

Date Posted: 10/18/2018

Job Snapshot

Job Description

  • Develops and implements processes involved with maintaining annual licenses, registrations, and listings
    Reviews and approves advertising and promotion to ensure regulatory compliance
    Assures postmarket regulatory requirements are met (e.g. required reports, supplemental submissions and other postmarketing 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

Work From Home: Yes

Travel Percentage: Up to 25%

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