Staff Regulatory Affairs Specialist in Carrigtohill at Stryker Corporation

Date Posted: 11/16/2020

Job Snapshot

Job Description

Permanent role usually based in Carrigtwohill, Cork. Currently work from home. Can be fully remote

This role would suit someone with experience with drug devices and/or PMA regulatory experience

Possesses and applies a broad knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

  • Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies  
  • Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature  
  • 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
  • Provides regulatory input and technical guidance on global regulatory requirements to product development teams
  • Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
  • Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
  • Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
  • Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
  • Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
  • Provides regulatory information and guidance for proposed product claims/labeling
  • Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
  • Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
  • Monitors the progress of the regulatory authority review process through appropriate communications with the agency
  • Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
  • Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees



Education / work experience

  • BS in Engineering, Science,  or related or MS in Regulatory Science                
  • Typically a minimum of 5 years experiences in the medical device industry
  • PMA regulatory experience preferred
  • Strong project management, writing, coordination, and execution of  regulatory items
  • Emphasis on technical and scientific regulatory activities
  • Demonstrated knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, post marketing surveillance/vigilance and distribution
  • Navigates the dynamics, alliances, and competing requirements of the organization or business
  • Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities

Work From Home: Regularly scheduled days

Travel Percentage: 10%

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