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Staff Regulatory Affairs Specialist, Cork
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Client:
Stryker European Operations Limited
Location:
Cork, Ireland
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
97d167e11046
Job Views:
4
Posted:
01.07.2025
Expiry Date:
15.08.2025
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Job Description:
Work Flexibility: Hybrid or Onsite
Key Areas of Responsibility:
* 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 provides internal advice throughout the product lifecycle (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 and distribution (federal, provincial/territorial, reimbursement, purchasing groups, etc.)
* Assists in the development of regulatory strategy and updates it based on 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 guidance for product development and planning throughout the product lifecycle
* Compares regulatory outcomes with initial product concepts and recommends changes or refinements
* Negotiates with regulatory authorities throughout the product lifecycle
* Identifies the need for new regulatory procedures, SOPs, and participates in their development and implementation
* Helps train stakeholders on current and new regulatory requirements
* Assists in developing SOPs to ensure regulatory compliance
* Provides regulatory input and guidance on global requirements to product development teams
* Advises stakeholders on regulatory requirements for quality, preclinical, and clinical data
* Assesses the acceptability of documents for submission to comply with regulations
* Evaluates proposed changes for regulatory filing solutions and strategizes accordingly
* Provides knowledge on preapproval and GCP inspections and investigator relationships
* Identifies, monitors, and submits reports to regulatory authorities during clinical research
* Provides regulatory guidance on product claims/labeling
* Ensures data and regulatory strategy support proposed product claims
* Prepares and submits regulatory documents electronically and on paper
* Monitors review process and communicates with regulatory agencies
* Interacts with authorities before and during submission review
* Works with cross-functional teams for interactions with regulatory authorities
Education / Work Experience:
* BS in Engineering, Science, or related degree; or MS in Regulatory Science
* Typically a minimum of 4 years’ experience
* MS or RAC(s) preferred
Knowledge / Competencies:
* Regulatory strategy, operations, and management skills
* Knowledge of regulatory pathways, risk-benefit analysis, submission, approval, compliance, and postmarketing surveillance
* Ability to plan, conduct, and supervise assignments with some latitude for decision-making
* Experience in reviewing progress and recommending procedural changes
* Ability to navigate organizational dynamics and collaborate effectively
* Willingness to accept challenging assignments and pursue growth opportunities
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Travel Percentage: 20%
Note: If you are not a passport holder of the country for the vacancy, a work permit might be required. Check our Blog for more information.
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