Comrise
Overview
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This range is provided by Comrise. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $85.00/hr - $90.00/hr Responsibilities
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 Assesses 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 Seniority level
Mid-Senior level Employment type
Contract Job function
Manufacturing and Quality Assurance Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at Comrise by 2x Inferred from the description for this job
Regulatory Affairs Specialist-Medical Device Regulatory Affairs Specialist- Cosmetic/Drugs Northfield, IL $79,560 - $115,440 5 days ago Northfield, IL $79,560 - $115,440 23 hours ago Buffalo Grove, IL $70,000 - $75,000 3 weeks ago North Chicago, IL $177,000 - $336,000 1 week ago Deerfield, IL $136,000 - $187,000 2 months ago Associate Director, Regulatory Affairs CMC - Hybrid Onsite
North Chicago, IL $137,500 - $261,000 23 hours ago Clinical Quality Documentation Specialist, Full-time, Days, Hybrid ($4,000 sign-on bonus)
Sr Manager Regulatory Affairs - Labeling, Advertising and Promotions (Remote)
Des Plaines, IL $160,000 - $200,000 6 days ago Clinical Quality Documentation Specialist, Full-time, Days, Hybrid ($4,000 sign-on bonus)
Associate Director, Regulatory Affairs CMC - Hybrid Onsite
North Chicago, IL $137,500 - $261,000 6 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Get AI-powered advice on this job and more exclusive features. Compensation
This range is provided by Comrise. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $85.00/hr - $90.00/hr Responsibilities
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 Assesses 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 Seniority level
Mid-Senior level Employment type
Contract Job function
Manufacturing and Quality Assurance Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at Comrise by 2x Inferred from the description for this job
Regulatory Affairs Specialist-Medical Device Regulatory Affairs Specialist- Cosmetic/Drugs Northfield, IL $79,560 - $115,440 5 days ago Northfield, IL $79,560 - $115,440 23 hours ago Buffalo Grove, IL $70,000 - $75,000 3 weeks ago North Chicago, IL $177,000 - $336,000 1 week ago Deerfield, IL $136,000 - $187,000 2 months ago Associate Director, Regulatory Affairs CMC - Hybrid Onsite
North Chicago, IL $137,500 - $261,000 23 hours ago Clinical Quality Documentation Specialist, Full-time, Days, Hybrid ($4,000 sign-on bonus)
Sr Manager Regulatory Affairs - Labeling, Advertising and Promotions (Remote)
Des Plaines, IL $160,000 - $200,000 6 days ago Clinical Quality Documentation Specialist, Full-time, Days, Hybrid ($4,000 sign-on bonus)
Associate Director, Regulatory Affairs CMC - Hybrid Onsite
North Chicago, IL $137,500 - $261,000 6 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr