Katalyst CRO
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Regulatory Affairs Associate
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Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Associate
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Katalyst CRO Get AI-powered advice on this job and more exclusive features. Job Description
Check below to see if you have what is needed for this opportunity, and if so, make an application asap.
Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes. Job Description
Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes.
Responsibilities
Develop and design compliant labeling, including IFUs and international labels. Coordinate cross-functional teams and manage multiple labeling projects. Implement changes per international regulatory guidelines. Fill out forms, revue redlines and submit packages to the labeling team. Track labeling change requests and maintain documentation for audits. Monitor global regulatory trends and update internal procedures. Support quality system improvements and KPI reporting.
Requirements :
Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or related field. 4+ years in regulatory/quality operations within a regulated industry. Experience with labeling design, document control, and regulatory submissions. Strong knowledge of FDA and international device labeling regulations. Proficiency in SAP, Adobe Acrobat, and MS Office. Experience with Class III implantable medical devices. Hands-on with PMA supplements, change assessments, and audit preparation. Strong project coordination and stakeholder communication skills. Seniority level
Seniority levelAssociate Employment type
Employment typeContract Job function
Job functionLegal IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Regulatory Affairs Associate” roles. San Jose, CA $80,000.00-$90,000.00 4 months ago Union City, CA $100,000.00-$120,000.00 1 week ago Regulatory Affairs Specialist - (NMPA/CFDA) Sunnyvale, CA $97,600.00-$165,200.00 2 days ago Sunnyvale, CA $97,600.00-$165,200.00 2 days ago Sunnyvale, CA $80,900.00-$128,800.00 1 week ago Health Transactional/Regulatory Associate Milpitas, CA $115,000.00-$150,000.00 2 days ago Sr Regulatory Affairs Specialist (Remote) - ShockwaveSr Regulatory Affairs Specialist (Remote) - Shockwave Santa Clara, CA $89,000.00-$165,600.00 17 hours ago Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - ShockwaveSenior Regulatory Affairs Specialist - Vascular (on-site)Senior Regulatory Affairs Specialist -Vascular (on-site)Regulatory Affairs Compliance Specialist - Pleasanton, CA Pleasanton, CA $115,000.00-$125,000.00 9 hours ago Sr Regulatory Affairs Specialist - Shockwave MedicalSenior Regulatory Affairs Specialist – Vascular (on-site) Sunnyvale, CA $80,000.00-$140,000.00 7 months ago Regulatory Affairs Manager – Heart Failure (on-site) Pleasanton, CA $112,000.00-$224,000.00 1 week ago Regulatory Affairs Manager – Vascular (on-site) Santa Clara, CA $112,000.00-$224,000.00 1 month ago San Francisco Bay Area $148,400.00-$162,400.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Regulatory Affairs Associate
role at
Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Associate
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Job Description
Check below to see if you have what is needed for this opportunity, and if so, make an application asap.
Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes. Job Description
Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes.
Responsibilities
Develop and design compliant labeling, including IFUs and international labels. Coordinate cross-functional teams and manage multiple labeling projects. Implement changes per international regulatory guidelines. Fill out forms, revue redlines and submit packages to the labeling team. Track labeling change requests and maintain documentation for audits. Monitor global regulatory trends and update internal procedures. Support quality system improvements and KPI reporting.
Requirements :
Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or related field. 4+ years in regulatory/quality operations within a regulated industry. Experience with labeling design, document control, and regulatory submissions. Strong knowledge of FDA and international device labeling regulations. Proficiency in SAP, Adobe Acrobat, and MS Office. Experience with Class III implantable medical devices. Hands-on with PMA supplements, change assessments, and audit preparation. Strong project coordination and stakeholder communication skills. Seniority level
Seniority levelAssociate Employment type
Employment typeContract Job function
Job functionLegal IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Regulatory Affairs Associate” roles. San Jose, CA $80,000.00-$90,000.00 4 months ago Union City, CA $100,000.00-$120,000.00 1 week ago Regulatory Affairs Specialist - (NMPA/CFDA) Sunnyvale, CA $97,600.00-$165,200.00 2 days ago Sunnyvale, CA $97,600.00-$165,200.00 2 days ago Sunnyvale, CA $80,900.00-$128,800.00 1 week ago Health Transactional/Regulatory Associate Milpitas, CA $115,000.00-$150,000.00 2 days ago Sr Regulatory Affairs Specialist (Remote) - ShockwaveSr Regulatory Affairs Specialist (Remote) - Shockwave Santa Clara, CA $89,000.00-$165,600.00 17 hours ago Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - ShockwaveSenior Regulatory Affairs Specialist - Vascular (on-site)Senior Regulatory Affairs Specialist -Vascular (on-site)Regulatory Affairs Compliance Specialist - Pleasanton, CA Pleasanton, CA $115,000.00-$125,000.00 9 hours ago Sr Regulatory Affairs Specialist - Shockwave MedicalSenior Regulatory Affairs Specialist – Vascular (on-site) Sunnyvale, CA $80,000.00-$140,000.00 7 months ago Regulatory Affairs Manager – Heart Failure (on-site) Pleasanton, CA $112,000.00-$224,000.00 1 week ago Regulatory Affairs Manager – Vascular (on-site) Santa Clara, CA $112,000.00-$224,000.00 1 month ago San Francisco Bay Area $148,400.00-$162,400.00 1 month 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