Senior RA Compliance Specialist in Carrigtohill at Stryker Corporation

Date Posted: 11/26/2019

Job Snapshot

Job Description

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 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: Not available

Travel Percentage: 0%

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