Katalyst CRO
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Regulatory Affairs Specialist I
role at
Katalyst CRO Join to apply for the
Regulatory Affairs Specialist I
role at
Katalyst CRO This position will have direct responsibility for review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files. Provides regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards. Reviews and approves labeling, advertising, and promotional materials, and manages translations for country registrations. Assists in developing regulatory strategies for new and modified products to achieve clearance/approval. Research scientific and regulatory information to develop labeling requirements and reviews verification/validation and risk management reports for accuracy. Assesses product, manufacturing, and labeling changes for regulatory impact and compliance. Develops internal procedures and tools, and conducts informational or training sessions for stakeholders.
Responsibilities
This position will have direct responsibility for review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files. Provides regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards. Reviews and approves labeling, advertising, and promotional materials, and manages translations for country registrations. Assists in developing regulatory strategies for new and modified products to achieve clearance/approval. Research scientific and regulatory information to develop labeling requirements and reviews verification/validation and risk management reports for accuracy. Assesses product, manufacturing, and labeling changes for regulatory impact and compliance. Develops internal procedures and tools, and conducts informational or training sessions for stakeholders.
Requirements:
Bachelor's degree (BS/BA) in any biological science or technical degree. 2+ years experience in Regulatory Affairs with 1-3 years of progressively responsible positions. Organizes and maintains department files and keeps informed of global regulatory information. Demonstrates commitment to the Company Quality Management System per ISO, FDA, and other regulatory agencies. Exhibits professional behaviour with internal/external business associates, reflecting positively on the company. Understands the quality consequences of improper job performance and is aware of potential device defects in their area of responsibility. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Legal Industries
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Regulatory Affairs Specialist I
role at
Katalyst CRO Join to apply for the
Regulatory Affairs Specialist I
role at
Katalyst CRO This position will have direct responsibility for review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files. Provides regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards. Reviews and approves labeling, advertising, and promotional materials, and manages translations for country registrations. Assists in developing regulatory strategies for new and modified products to achieve clearance/approval. Research scientific and regulatory information to develop labeling requirements and reviews verification/validation and risk management reports for accuracy. Assesses product, manufacturing, and labeling changes for regulatory impact and compliance. Develops internal procedures and tools, and conducts informational or training sessions for stakeholders.
Responsibilities
This position will have direct responsibility for review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files. Provides regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards. Reviews and approves labeling, advertising, and promotional materials, and manages translations for country registrations. Assists in developing regulatory strategies for new and modified products to achieve clearance/approval. Research scientific and regulatory information to develop labeling requirements and reviews verification/validation and risk management reports for accuracy. Assesses product, manufacturing, and labeling changes for regulatory impact and compliance. Develops internal procedures and tools, and conducts informational or training sessions for stakeholders.
Requirements:
Bachelor's degree (BS/BA) in any biological science or technical degree. 2+ years experience in Regulatory Affairs with 1-3 years of progressively responsible positions. Organizes and maintains department files and keeps informed of global regulatory information. Demonstrates commitment to the Company Quality Management System per ISO, FDA, and other regulatory agencies. Exhibits professional behaviour with internal/external business associates, reflecting positively on the company. Understands the quality consequences of improper job performance and is aware of potential device defects in their area of responsibility. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Legal Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Specialist jobs in
San Diego, CA . Staff Regulatory Affairs Specialist - Becton Dickinson
Sr Regulatory Affairs Specialist (Remote) - Shockwave
Associate Regulatory Affairs Manager (Onsite)
Staff International Regulatory Affairs Specialist
Specialist, Regulatory Strategy - San Diego (Onsite)
Staff International Regulatory Affairs Specialist - Becton Dickinson
Manager/Senior Manager, Regulatory Affairs
Associate Director of Regulatory Affairs
Associate Director of Regulatory Affairs
Associate Director of Regulatory Affairs
Staff Specialist Regulatory Affairs (Hybrid)
San Diego Metropolitan Area $130,000.00-$190,000.00 4 days ago San Diego County, CA $140,000.00-$170,000.00 16 hours ago Associate Director, Regulatory Affairs CMC - San Diego, CA
Manager, Regulatory Affairs - Hybrid - 134458
San Diego Metropolitan Area $55.00-$65.00 4 days ago Manager, Regulatory Affairs (IVD On-Market/Sustaining)
Associate Director Regulatory Affairs - Becton Dickinson
Regulatory Affairs Manager - IVD and 510K
Manager/ Sr. Manager, Regulatory Affairs
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr