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Principal Regulatory Affairs Specialist – Ledgent Technology
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Principal Regulatory Affairs Specialist
role at
Jobs via Dice
Dice is the leading career destination for tech experts at every stage of their careers. Our client, Ledgent Technology, is seeking the following. Apply via Dice today!
Job Description:
Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
Remediation of regulatory documentation in accordance with relevant regulatory requirements for US 510(k)
Remediation of EU MDR Technical Documentation File in accordance with relevant regulatory requirements for Class IIa medical device
Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
Provides guidance to integrate regulatory considerations into global product entry and exit strategy
Assess all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
Negotiates with regulatory authorities on complex issues throughout the product lifecycle
Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
Provides regulatory guidance on strategy for proposed product claims/labeling
Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
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Principal Regulatory Affairs Specialist
role at
Jobs via Dice
Dice is the leading career destination for tech experts at every stage of their careers. Our client, Ledgent Technology, is seeking the following. Apply via Dice today!
Job Description:
Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
Remediation of regulatory documentation in accordance with relevant regulatory requirements for US 510(k)
Remediation of EU MDR Technical Documentation File in accordance with relevant regulatory requirements for Class IIa medical device
Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
Provides guidance to integrate regulatory considerations into global product entry and exit strategy
Assess all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
Negotiates with regulatory authorities on complex issues throughout the product lifecycle
Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
Provides regulatory guidance on strategy for proposed product claims/labeling
Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
#J-18808-Ljbffr