- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply ... of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.… more
- Cepheid (Miami, FL)
- …manner with effective corrective action. Participate in external audit management (eg FDA , ISO, Danaher Corporate, foreign governments), in either a supporting or ... federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well… more
- Beckman Coulter Diagnostics (Miami, FL)
- …to internal quality standards, customer requirements, and applicable external regulatory frameworks. Provide structured feedback and corrective action follow-up to ... risks.Collaborate with cross-functional teams across R&D, Procurement, Operations, Quality, and Regulatory Affairs to embed quality into all phases of the product… more
- Aldevron (Miami, FL)
- …that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be on-site. At ... methods utilized at Aldevron are qualified/validated in accordance with current regulatory expectations, in a phase-appropriate manner.This role is onsite in our… more
- Sanofi Group (Framingham, MA)
- …and roll-out of the Sanofi Quality Management System in line with US FDA cGMP regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi ... **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, Morristown, NJ **Job...secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity,… more
- Bayer (NJ)
- …Bayer seeks an incumbent who possesses the following: **Required Qualifications:** + US FDA regulatory experience in related drug or device area; + Demonstrated ... Acts as a critical collaborative partner with the Global Regulatory Affairs organization to ensure FDA /US input...the Global Regulatory Affairs organization to ensure FDA /US input into product development; + Represents US … more
- BeOne Medicines (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
- J&J Family of Companies (Horsham, PA)
- …subject to applicable laws, regulations, guidelines and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines ... pharmaceutical or biopharmaceutical industry is required. + Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and… more
- Xcelerate Solutions (Frederick, MD)
- …trend knowledge points and risks through the medical portfolio + Track and trend FDA regulatory intelligence + Assist with full lifecycle project management and ... Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking...for pharmaceutical development and within the constraints of the FDA approval process + Plan and provide input to… more
- Actalent (Piscataway, NJ)
- …development of global regulatory strategies for a clinical laboratory. + Prepare regulatory submission documents for the FDA or other regulatory agencies ... Job Title: Quality Assurance and Regulatory Affairs SpecialistJob Description As a Quality Assurance...working knowledge of applicable regulations and standards (eg, ISO, FDA , CAP, CLIA, GMP, GCP, GLP, ICH, and other… more
- J&J Family of Companies (Santa Clara, CA)
- … regulatory requirements in the light of current guidance and FDA /International regulatory body field activity. **REQUIRED KNOWLEDGE, SKILLS, ABILITIES, ... Johnson & Johnson is hiring for a **Sr. Manager, Regulatory Compliance - Shockwave Medical** to join our team...managing internal audit program, expertise in ISO 13485, EUMDR, FDA CFR 820. + Preferred certifications on the following:… more
- IQVIA (Wayne, PA)
- …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the enhanced… more
- Fortive Corporation (Irvine, CA)
- …to regulatory affairs management in order to facilitate compliance with all FDA and other US and international regulatory requirements throughout the product ... regulations and interpretations. + Writes, coordinates, compiles, and submits Regulatory documents to FDA and other Regulatory Agencies, including EPA and… more
- Abbott (Santa Clara, CA)
- …of global regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class III medical devices and ... Clara, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** within **Abbott Ventures**… more
- Abbott (St. Paul, MN)
- …trial operations and product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory ... communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA... regulatory standards including those set by the FDA or other worldwide regulatory agencies to… more
- AbbVie (San Francisco, CA)
- …Advise internal customers who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs, Clinical Development, Legal, and ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, RA Global Regulatory Strategy, US & Canada position is responsible for the development… more
- Abbott (Plymouth, MN)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... timely manner to support Abbott customers. + May interface directly with FDA and other regulatory agencies if so directed. + Support all Company initiatives as… more
- Abbott (Plymouth, MN)
- … affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory ... regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies,… more
- Abbott (St. Paul, MN)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... and approving requests for product release. * May interface directly with FDA and other regulatory agencies if so directed. * Reviews protocols and reports to… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …Director might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements (affairs and CMC) for investigational and ... management. + Responsible for the strategic company guidance on FDA and global regulatory CMC requirements for investigational and commercial products + Directs… more
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