- Abbott (Alameda, CA)
- …hiring for a ** Regulatory Affairs Specialist ,** as part of the Regulatory Affairs Asia Pacific (APAC) team, on-site at our Diabetes Care Division ... HQ location in Alameda, CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory … more
- J&J Family of Companies (Jacksonville, FL)
- Sr Regulatory Affairs Specialist -...for Europe, Middle East, Africa (EMEA), Latin America and Asia Pacific as needed This individual will drive the ... of the Johnson & Johnson Family of Companies, is currently seeking a Senior Regulatory Affairs Specialist to be based in Jacksonville, FL or Irvine, CA or… more
- Actalent (Carlsbad, CA)
- *Must have EU regulatory experience with MDD and MDR. Description: The Sr. Regulatory Affairs Specialist - Europe participates and manages necessary ... in accordance with MDD and MDR. * Assist the Regulatory Affairs Director with Regulatory ...and more than 4,500 clients across the US, Canada, Asia and Europe, Actalent serves many of the Fortune… more
- Edwards Lifesciences (Irvine, CA)
- …. **How you will make an impact:** As a Senior Specialist , International Regulatory Affairs , you complete and ... us achieve our goals:** + Experience with strong input/authoring 510(k)s + Regulatory affairs experience with software devices and product development **What… more
- Actalent (Franklin, IN)
- Description: This position will report directly to the regulatory affairs director. This role involves preparing documentation to support international product ... and Health Canada is part of the responsibilities. Skills: Regulatory affairs , Medical device, Regulatory ...and more than 4,500 clients across the US, Canada, Asia and Europe, Actalent serves many of the Fortune… more
- Actalent (Cuyahoga Falls, OH)
- …in accordance with cGMPs, QSRs, MDRs and the Quality Management System. Skills: Regulatory affairs , Regulatory , Medical device, FDA, Regulatory ... 21cfr 820, Labelling, Quality assurance, Compliance Top Skills Details: Regulatory affairs , Regulatory , Medical device,...and more than 4,500 clients across the US, Canada, Asia and Europe, Actalent serves many of the Fortune… more
- ICP Group (Andover, MA)
- … Asia Pacific region. ICP Group is looking to identify a Product Safety & Regulatory Affairs Specialist . The PSRA Specialist ensures that all ... post-commercialization) are conducted in accordance with the current domestic and global regulatory statutes that govern the respective industries for ICP to meet… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... domestic and international regulatory environments. Working in...operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For… more
- Actalent (Louisville, CO)
- …of departmental standard operating procedures with management and team. . Follows internal regulatory affairs policy and procedures. . Assist with internal and ... will have broad and critical responsibilities that include supporting regulatory compliance to the Company's (all sites) Quality Management...and more than 4,500 clients across the US, Canada, Asia and Europe, Actalent serves many of the Fortune… more
- Actalent (Franklin, IN)
- …lines used for orthodontic clients. This position will report directly to the regulatory affairs director. This role involves preparing documentation to support ... as tracking documents needed for product registrations within the company's regulatory framework. The position entails participating in inspections and audits… more
- Actalent (Cuyahoga Falls, OH)
- …or other technology field is preferred. + 3-5 years of progressive experience in regulatory affairs required + Prior knowledge of 21CFR 820, ISO13485, MDR QMS ... DESCRIPTION: + Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical...and more than 4,500 clients across the US, Canada, Asia and Europe, Actalent serves many of the Fortune… more
- Lilly (IN)
- …"patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for ... expertise, and relevant clinical experience, the Lilly Diabetes and Obesity - Medical Affairs Physician is an integral member of the medical affairs ,… more
- State of Colorado (Denver, CO)
- Risk & Compliance Support Specialist (Program Asst. I): DORA/Division of Professions & Occupations Print ... (https://www.governmentjobs.com/careers/colorado/jobs/newprint/4509786) Apply Risk & Compliance Support Specialist (Program Asst. I): DORA/Division of Professions & Occupations… more
- Edwards Lifesciences (Riverside, CA)
- …Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. After extensive ... the world. As a part of the Field Clinical Specialist team, you will be a critical part of...operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For… more
- Edwards Lifesciences (Detroit, MI)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Actalent (Minneapolis, MN)
- …Market QA Manager of unusual or high-risk events requiring review by Legal or Regulatory Affairs . Maintains order, cleanliness, equipment calibration and PE lab ... the compliance of the company with FDA and international regulatory authorities. This position will be responsible for receiving,...and more than 4,500 clients across the US, Canada, Asia and Europe, Actalent serves many of the Fortune… more
- Actalent (Minneapolis, MN)
- …Market QA Manager of unusual or high-risk events requiring review by Legal or Regulatory Affairs + Maintains order, cleanliness, equipment calibration and PE lab ... the compliance of the company with FDA and international regulatory authorities. This position will be responsible for receiving,...and more than 4,500 clients across the US, Canada, Asia and Europe, Actalent serves many of the Fortune… more
- Edwards Lifesciences (Irvine, CA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Actalent (Foster City, CA)
- …such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Clinical/Commercial Drug Products are ... a wide variety of activities to ensure compliance with applicable regulatory requirements. * Participates in developing Standard Operating Procedures (SOPs) to… more
- Edwards Lifesciences (Irvine, CA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more