- Edwards Lifesciences (Irvine, CA)
- …. **How you will make an impact:** As a Senior Specialist , Regulatory Affairs , you work with other ... critical care devices in NPD stages. You manage all Regulatory Affairs activities within the US, EU...operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For… more
- 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)
- Description: The Sr. Regulatory Affairs Specialist - Europe participates and manages necessary regulatory and project management activities required for ... 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
- Actalent (Aliso Viejo, CA)
- …will be working with multiple business units to develop update and improve regulatory affairs processes. Assist the strategy implementation and operations for ... regulatory affairs activities including directing development of...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 be part of our inspiring journey. **How you will make an impact:** As a Specialist , Regulatory Affairs for TMTT, you will complete and maintain clinical ... patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative...operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For… more
- Actalent (Laguna Hills, CA)
- Description: This position is a regulatory affairs specialist for a medical device company. Individual must be knowledgeable in medical device industry and ... maintain Adagio compliance. Post-market and vigilance reporting process. Represent Regulatory Affairs on Engineering & R&D product...and more than 4,500 clients across the US, Canada, Asia and Europe, Actalent serves many of the Fortune… more
- Actalent (Carlsbad, CA)
- Description: The Sr. Regulatory Affairs Specialist - Europe participates and manages necessary regulatory and project management activities required for ... Files 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'll make an impact:** As a Senior Specialist , International Regulatory Affairs , you complete ... approvals and clearances of assigned products. + Creating complex regulatory submissions (exercising judgment to protect proprietary information) for finalization… 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 (Bedford, MA)
- **Language fluency required: English & Chinese essential** Position Summary: The Regulatory Specialist will be responsible for China NMPA and Japan PMDA ... participation on design and risk management teams, initiation of regulatory plans for both new products and significant product...and more than 4,500 clients across the US, Canada, Asia and Europe, Actalent serves many of the Fortune… more
- Actalent (Bedford, MA)
- …design and risk management teams (both Hemostasis and Acute Care) as the regulatory representative and provide guidance on China NMPA and Japan PMDA requirements, ... including: Author and sign Regulatory Plans on regulatory requirements for worldwide...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
- Actalent (Sharonville, OH)
- …meeting customer expectations. - Work to provide solutions, rather than just answers. Skills: Regulatory , Regulatory affairs , Fda, Regulatory documents, ... Description: The role of the Quality Specialist is to provide regulatory support...dietary supplements, regulatory systems Top Skills Details: Regulatory , Regulatory affairs ,Fda, Regulatory documents,… more
- Actalent (Lemont, IL)
- …documents. Additional Skills & Qualifications: + Bachelors Degree + 3 years in Regulatory Affairs within the food industry + Experience creating ingredient fact ... + Create and update ingredient declarations, nutrition panels, and appropriate regulatory documents. + Work cross functionally within the organization. + Create… more
- Actalent (Newark, CA)
- …will be interacting with cross-functional groups such as Quality Control, Manufacturing and Regulatory Affairs . + Perform a wide variety of quality assurance ... Hiring a Quality Assurance Specialist II in Newark, CA. Job Description Quality...to ensure compliance with procedures, applicable US and international regulatory requirements for biologic drug substances and drug products… more
- Actalent (Maryland Heights, MO)
- …Prepare logbooks and issue logbooks and notebooks for use across the site. Support Regulatory Affairs (US and Canada) by assisting in gathering information for ... Description: The Contract Quality Systems Documentation Specialist is responsible for assisting in the management and administration of the Document Control systems… more
- Edwards Lifesciences (Las Vegas, NV)
- …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
- Actalent (Torrance, CA)
- …well as new FDA or ICH regulatory changes. ❖ Partner with Regulatory Affairs , Manufacturing, Development, Marketing as well as Corporate Quality on customer ... Control Support ❖ Back up activities of Quality Assurance Specialist (Operations) which includes working on: deviations, batch record...projects, regulatory submissions, and harmonization of PPL Group's Global Quality… more