Regulatory Affairs Specialist 3
4 weeks ago
Job ScopeThe Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. Relies on extensive experience and judgment to plan, create, develop and maintain materials needed for regulatory compliance. Uses technical knowledge to drive new product submissions, listings, and registration of medical devices. Trains and mentors lower-level specialists in regulatory activities.ResponsibilitiesEnsures all processes for the essential functions are documented in procedures.Performs internal departmental audits and supports audits by third parties e.g., BSI, FDA and others, as required.Initiates and maintains required establishment listings e.g., FDA and EU, including renewal or changes.Develops company regulatory strategies and prioritization. Determines the best strategy to register new products in specific global markets.Determines appropriate product testing to support registration activities.Ensures content accuracy and regulatory compliance for submission to regulatory agencies e.g., 510(k), PMA, MDR Technical Files/Design Dossiers, global registration applications, etc.Provides feedback / approval of compliant labeling e.g., IFUs, marketing materials, package labels, etc.Manages and leads responses to Regulatory Agency for submission deficiencies.Maintains accurate international product registration, including renewal or changes, and certificates for foreign governments.Provides direction/guidance as needed to other Regulatory Specialists.Qualifications5+ years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)Evidence of applied knowledge of applicable FDA, ISO, MDR requirements, consensus standards and guidance documents.Ability to work under limited supervision with FDA, Notified Body, EU Authorized Representative, and other global regulatory agencies.Able to manage multiple projects simultaneously.Proven track record of strong teamwork, creatively strategic thinking.Ability to work well with others, support regulatory activities and mentor/train others.Excellent written and verbal communication skills.Master of Science in Regulatory Affairs preferred.Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.
-
Regulatory Affairs Specialist 3
2 weeks ago
Addison, TX, United States Cedent Full timeThe Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. Relies on extensive experience and judgment to plan, create, develop and maintain materials needed for regulatory compliance. Uses technical knowledge to drive new product submissions, listings, and...
-
Regulatory Affairs Specialist
3 weeks ago
Addison, IL, United States Walker Lovell Full timeRegulatory Specialist Location Addison Illinois (Hybrid) Travel: Minimal Shape Compliance in a Flavor-Forward Industry This role will allow you to drive compliance across a diverse portfolio of flavor and ingredient systems. This is a high-impact role where your regulatory insight and scientific acumen will directly support innovation, product...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Addison, United States Walker Lovell Full timeThis range is provided by Walker Lovell. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $80,000.00/yr - $105,000.00/yr Direct message the job poster from Walker Lovell Senior Regulatory Specialist Location: Addison, IL (Hybrid – On‑site Tue–Thu) Compensation: Competitive with...
-
CMC Regulatory Affairs Consultant
2 days ago
Addison, TX, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products. Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and...
-
CMC Regulatory Affairs Consultant
2 days ago
Addison, TX, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products. Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and...
-
CMC Regulatory Affairs Consultant
2 weeks ago
Addison, TX, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products. Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and...
-
Regulatory Specialist
1 week ago
Addison, IL, United States Walker Lovell Full timeRegulatory SpecialistLocation Addison Illinois (Hybrid)Travel: MinimalCompensation: Reflecting seniority and scopeShape Compliance in a Flavor-Forward IndustryThis role will allow you to drive compliance across a diverse portfolio of flavor and ingredient systems. This is a high-impact role where your regulatory insight and scientific acumen will directly...
-
Regulatory Specialist
1 week ago
Addison, IL, United States Walker Lovell Full timeRegulatory SpecialistLocation Addison Illinois (Hybrid)Travel: MinimalCompensation: Reflecting seniority and scopeShape Compliance in a Flavor-Forward IndustryThis role will allow you to drive compliance across a diverse portfolio of flavor and ingredient systems. This is a high-impact role where your regulatory insight and scientific acumen will directly...
-
Regulatory Specialist
6 days ago
Addison, IL, United States Walker Lovell Full timeRegulatory SpecialistLocation Addison Illinois (Hybrid)Travel: MinimalCompensation: Reflecting seniority and scopeShape Compliance in a Flavor-Forward IndustryThis role will allow you to drive compliance across a diverse portfolio of flavor and ingredient systems. This is a high-impact role where your regulatory insight and scientific acumen will directly...
-
Regulatory Specialist
6 days ago
Addison, IL, United States Walker Lovell Full timeRegulatory SpecialistLocation Addison Illinois (Hybrid)Travel: MinimalCompensation: Reflecting seniority and scopeShape Compliance in a Flavor-Forward IndustryThis role will allow you to drive compliance across a diverse portfolio of flavor and ingredient systems. This is a high-impact role where your regulatory insight and scientific acumen will directly...
