Current jobs related to Associate Regulatory Affairs Specialist - El Segundo - Karl Storz Endoscopy-America
-
Director of Regulatory Affairs
4 weeks ago
El Segundo, United States Cameron Smith & Associates, Inc. Full timeWHAT WE ARE LOOKING FOR:The Director, Regulatory Affairs will serve as the leading expert in Scientific & Regulatory Affairs, overseeing all facets of U.S. and international regulations (EU, CAN, AUS, and others), alongside the management of 3rd party certifications for our entire product portfolio. A successful Director, Regulatory will establish...
-
Director of Regulatory Affairs
4 weeks ago
El Segundo, United States Cameron Smith & Associates, Inc. Full timeWHAT WE ARE LOOKING FOR:The Director, Regulatory Affairs will serve as the leading expert in Scientific & Regulatory Affairs, overseeing all facets of U.S. and international regulations (EU, CAN, AUS, and others), alongside the management of 3rd party certifications for our entire product portfolio. A successful Director, Regulatory will establish...
-
Director of Regulatory Affairs
4 weeks ago
el segundo, United States Cameron Smith & Associates, Inc. Full timeWHAT WE ARE LOOKING FOR:The Director, Regulatory Affairs will serve as the leading expert in Scientific & Regulatory Affairs, overseeing all facets of U.S. and international regulations (EU, CAN, AUS, and others), alongside the management of 3rd party certifications for our entire product portfolio. A successful Director, Regulatory will establish...
-
Regulatory Affairs Advertising
2 days ago
El Segundo, United States KARL STORZ Endoscopy - America Full timeJoin KARL STORZ, a leading medical device company, and play a crucial role in ensuring compliance and regulatory excellence! We're seeking a highly organized and detail-oriented Regulatory Affairs Advertising and Promotion (Ad Promo) Coordinator to manage our Advertising and Promotion review process. As a key member of our Regulatory Affairs team,...
-
Regulatory Affairs Advertising
2 days ago
El Segundo, United States KARL STORZ Endoscopy - America Full timeJoin KARL STORZ, a leading medical device company, and play a crucial role in ensuring compliance and regulatory excellence! We're seeking a highly organized and detail-oriented Regulatory Affairs Advertising and Promotion (Ad Promo) Coordinator to manage our Advertising and Promotion review process. As a key member of our Regulatory Affairs team,...
-
Regulatory Affairs Advertising
2 days ago
El Segundo, United States KARL STORZ Endoscopy - America Full timeJoin KARL STORZ, a leading medical device company, and play a crucial role in ensuring compliance and regulatory excellence! We're seeking a highly organized and detail-oriented Regulatory Affairs Advertising and Promotion (Ad Promo) Coordinator to manage our Advertising and Promotion review process. As a key member of our Regulatory Affairs team,...
-
Regulatory Affairs Advertising
3 days ago
El Segundo, United States KARL STORZ Endoscopy - America Full timeJoin KARL STORZ, a leading medical device company, and play a crucial role in ensuring compliance and regulatory excellence! We're seeking a highly organized and detail-oriented Regulatory Affairs Advertising and Promotion (Ad Promo) Coordinator to manage our Advertising and Promotion review process. As a key member of our Regulatory Affairs team,...
-
Regulatory Affairs Advertising
1 day ago
El Segundo, United States KARL STORZ Endoscopy - America Full timeJoin KARL STORZ, a leading medical device company, and play a crucial role in ensuring compliance and regulatory excellence! We're seeking a highly organized and detail-oriented Regulatory Affairs Advertising and Promotion (Ad Promo) Coordinator to manage our Advertising and Promotion review process. As a key member of our Regulatory Affairs team, you'll...
-
Regulatory Affairs Advertising
2 days ago
El Segundo, CA, United States KARL STORZ Endoscopy - America Full timeJoin KARL STORZ, a leading medical device company, and play a crucial role in ensuring compliance and regulatory excellence! We're seeking a highly organized and detail-oriented Regulatory Affairs Advertising and Promotion (Ad Promo) Coordinator to manage our Advertising and Promotion review process. As a key member of our Regulatory Affairs team,...
-
Regulatory Affairs Advertising
2 days ago
El Segundo, CA, United States KARL STORZ Endoscopy - America Full timeJoin KARL STORZ, a leading medical device company, and play a crucial role in ensuring compliance and regulatory excellence! We're seeking a highly organized and detail-oriented Regulatory Affairs Advertising and Promotion (Ad Promo) Coordinator to manage our Advertising and Promotion review process. As a key member of our Regulatory Affairs team,...
-
Regulatory Affairs Specialist
2 months ago
El Segundo, United States Cosmetix West Full timeJob DescriptionJob DescriptionSalary: $28-$30/hour DOE Job Duties Manage collection of raw material documents Obtain technical/regulatory documentation from raw material vendors Manage and prepare documentation related to a specific formula including preparing PIL, IL, SDS, QQ, and coordination of testing (upon customer’s needs). Helps prepare...
-
Regulatory Affairs Advertising
2 days ago
El Segundo, California, 90245, Los Angeles County, CA, United States KARL STORZ Endoscopy - America Full timeJoin KARL STORZ, a leading medical device company, and play a crucial role in ensuring compliance and regulatory excellence! We're seeking a highly organized and detail-oriented Regulatory Affairs Advertising and Promotion (Ad Promo) Coordinator to manage our Advertising and Promotion review process. As a key member of our Regulatory Affairs team,...
-
Regulatory Affairs Medical Writer
4 weeks ago
El Segundo, California, United States ImmunityBio Full timeJoin Our Innovative TeamImmunityBio is seeking a skilled Medical Writer to enhance our documentation efforts. In this role, you will be tasked with producing high-quality regulatory submissions, including clinical study reports, protocols, and informed consent documents. You will work closely with various teams to ensure that all materials are accurate and...
-
Medical Director, U.S. Medical Affairs
2 days ago
El Segundo, United States KARL STORZ Endoscopy - America Full timeThis is a remote opportunity Travel: Occasional travel based on business need Why you will love this role: As the Medical Director, Medical Affairs, you will play a pivotal leadership role in providing expert clinical guidance across multidisciplinary teams. This position involves supporting Legal, Regulatory, Compliance, R&D, and Commercial teams...
-
Medical Director, U.S. Medical Affairs
2 days ago
El Segundo, United States KARL STORZ Endoscopy - America Full timeThis is a remote opportunity Travel: Occasional travel based on business need Why you will love this role: As the Medical Director, Medical Affairs, you will play a pivotal leadership role in providing expert clinical guidance across multidisciplinary teams. This position involves supporting Legal, Regulatory, Compliance, R&D, and Commercial teams...
-
Financial Examiner
3 weeks ago
El Segundo, California, United States Manpower Inc Full timeAbout the RoleWe are seeking a highly skilled Financial Examiner to join our team at Manpower Inc. As a Legal Claims Specialist, you will be responsible for conducting thorough research and analysis of financial documents to support our clients in the legal industry.Key ResponsibilitiesInteract with Clients and Professionals: Provide exceptional service to...
-
Medical Director, U.S. Medical Affairs
3 days ago
El Segundo, United States KARL STORZ Endoscopy - America Full timeThis is a remote opportunity Travel: Occasional travel based on business need Why you will love this role: As the Medical Director, Medical Affairs, you will play a pivotal leadership role in providing expert clinical guidance across multidisciplinary teams. This position involves supporting Legal, Regulatory, Compliance, R&D, and Commercial teams...
-
Medical Director, U.S. Medical Affairs
1 day ago
El Segundo, United States KARL STORZ Endoscopy - America Full timeThis is a remote opportunity Travel: Occasional travel based on business need Why you will love this role:As the Medical Director, Medical Affairs, you will play a pivotal leadership role in providing expert clinical guidance across multidisciplinary teams. This position involves supporting Legal, Regulatory, Compliance, R&D, and Commercial teams with...
-
Medical Director, U.S. Medical Affairs
3 days ago
El Segundo, United States KARL STORZ Endoscopy - America Full timeThis is a remote opportunity Travel: Occasional travel based on business need Why you will love this role: As the Medical Director, Medical Affairs, you will play a pivotal leadership role in providing expert clinical guidance across multidisciplinary teams. This position involves supporting Legal, Regulatory, Compliance, R&D, and Commercial teams...
-
Registered Nurse
3 weeks ago
El Paso, Texas, United States Department of Veterans Affairs Full timeJob SummaryWe are seeking a highly skilled Registered Nurse to join our team at the Department of Veterans Affairs. As a Registered Nurse, you will play a critical role in providing high-quality patient care and contributing to the overall success of our healthcare team.Key ResponsibilitiesProvide direct patient care, including assessing, planning,...
Associate Regulatory Affairs Specialist
3 months ago
KARL STORZ is currently recruiting for an Associate Regulatory Affairs Specialist who will be responsible for assisting the US Regulatory Affairs Team in preparing, organizing, and maintaining documentation required for regulatory compliance. This position also assists in communicating product clearance information to other departments within the organization and to external distributors and agencies.
Responsibilities
- To be knowledgeable at all times of current and emerging regulatory requirements affecting the business regarding actions necessary to obtain or maintain compliance with applicable regulations.
- Report to Senior Manager, Regulatory Affairs on the performance of Regulatory items.
- To regularly survey the Regulatory environment, and provide communication and special reports as necessary, to ensure that the company remains aware of significant events or issues which could have a substantial effect (positive or negative) on it.
- Maintain high levels of work and accountability.
- Help define strategy and provides guidance and support on regulatory requirements to new product development and sustaining projects from initial kick-off to post-marketing phase for US and Canada markets.
- Assist and support FDA and Health Canada submissions of simple complexity through to clearance/approvals.
- Reviews and approves engineering change orders.
- Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management, as required.
- Assist in registering products in any other countries as needed.
- Prepare briefing documents for and participate in internal regulatory meetings and meetings with regulatory authorities as necessary.
- Other incidental duties
Requirements
- Bachelors degree plus 1-3 years of experience in a highly regulated industry; or 0-1 year of experience with Masters degree in Regulatory
- Excellent problem-solving, organizational, analytical and critical thinking skill
- Demonstrates initiative to organizational and process improvements.
- Ability to manage multiple projects from start to completion.
- Solid PC skills (MS Office Suite, etc.)
- Excellent communication skills
- Exceptional organizational skills
- Strong attention to detail
- Ability to manage competing priorities in a fast-paced environment.
- Eagerness to learn
- Demonstrated experience building strategic partnerships to further departmental and organizational objective.
- Ability to travel up to 25%
Preferences
- 3+ years of experience in a highly regulated industry or within KS organization
- Bachelor degree or higher in scientific or engineering field or in regulatory affairs discipline.
- Hands on experience using SAP
LI-CW1
