Join to apply for the
Staff Specialist, Regulatory Affairs
role at
Stryker
.
This is a 12 month contract with full Stryker benefits.
What you will do
Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
Participates in advocacy activities of a technical and/or tactical nature.
Evaluates the regulatory environment and contributes to providing 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 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 documents for submission filing to comply with applicable regulations.
Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategies (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 clinical and nonclinical data, in conjunction with regulatory strategy, are aligned with 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.
What you will need
BS in Engineering, Science, or related degree; or MS in Regulatory Science.
Typically a minimum of 4 years' experience.
Location: Cork, Ireland (as applicable in posting).
Seniority level
Associate
Employment type
Full-time
Job function
Legal
Industries
Appliances, Electrical, and Electronics Manufacturing
Industrial Machinery Manufacturing
Medical Equipment Manufacturing
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