- Cytiva (Pensacola, FL)
- …Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance , and aligning with organizational quality ... Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device , Biopharma, or other FDA or EPA-regulated… more
- Beckman Coulter Diagnostics (Miami, FL)
- …and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union Medical ... Device Directives (MDD), and In-Vitro Medical Device Regulation (IVDR) as well as all other applicable global regulatory requirements.Maintain… more
- Cytiva (Miami, FL)
- …project engineering role, preferably in healthcare manufacturing or medical device production.2+ years experience with regulatory standards and quality ... into clear, concise language for a non-technical audience.Working in Pharmaceuticals or Medical Device industryExperience with Veeva & Magic systemsCytiva, a… more
- Cytiva (Miami, FL)
- …in Quality or Regulatory in a regulated industry (ISO 9001, medical device , or pharmaceutical preferred).Experience with root cause analysis, CAPA ... responsible for providing quality leadership in manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading… more
- Cytiva (Duncan, SC)
- …contamination control and sterility assurance within the pharmaceutical, biotechnology, or medical device industries.In-depth knowledge of regulatory ... change control processes related to contamination controls and sterility assurance.Ensure compliance with regulatory requirements and industry standards for… more
- Cytiva (Miami, FL)
- …walks.It would be a plus if you also possess previous experience in: Medical Device , eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949#LI-OnsiteJoin our ... suppliers to resolve non-conformance issues (QE Complaints and Deviations).Ensure supplier compliance to QMS and regulatory requirements through supplier… more
- Cytiva (Miami, FL)
- …walks.It would be a plus if you also possess previous experience in: Medical Device , eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949Speaking fluent ... suppliers to resolve non-conformance issues (QE Complaints and Deviations).Ensure supplier compliance to QMS and regulatory requirements through supplier… more
- Nissha Medical Technologies (Buffalo, NY)
- …looking to have a career in Regulatory , Quality and has an interest in Medical Device regulatory compliance . You will focus on becoming familiar ... with international Medical Device Regulatory compliance requirements, with a special focus on RA Compliance data collection activities for Buy &… more
- Bayer (Whippany, NJ)
- …842231 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Medical Device , Biomedical Engineering, Compliance , Regulatory Affairs, Product ... minimum of a BS degree is required; + Expert knowledge of regional and global medical device regulations (eg, EU MDR, Declarations of Conformity, CE Marking, ISO… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …knowledge or Critical Parameter Management. + Knowledge of global medical device regulations + Performed regulatory compliance assessments for US ... product life cycle on product project teams (eg developing regulatory and compliance strategies, compliance ...experience of skills/attributes listed below with medical device in Systems Engineering or Compliance Support… more
- Eurofins (Boston, MA)
- …a strategic vision and team to support our clients in the medical device industry across their product innovation, regulatory compliance , and quality ... as a strategic partner in their product innovation and regulatory compliance journeys. + Ensure client satisfaction...lead a team of skilled consultants with expertise in medical device testing, regulatory affairs,… more
- LCI-Lawinger Consulting (Minneapolis, MN)
- …will play a critical role in ensuring the safety, effectiveness, and regulatory compliance of medical device products. Key Responsibilities: + Lead and ... Engineering, or related field (or equivalent experience). + 5+ years of experience in medical device design assurance, with a deep understanding of FDA and ISO… more
- Cognizant (Chicago, IL)
- …discovery, Global Pharmaceutical market and industry, including BioTech, Medical Device , Traditional Rx, enabling technologies and regulatory / compliance ... **Experience Partner - Life Sciences (Pharma / BioTech / Medical Device )** **Associate Director - Chicago/Midwest Remote** **Who we are:** We are Cognizant… more
- Takeda Pharmaceuticals (Boston, MA)
- …patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager) Plasma-Derived Therapies ... Global Device Sub team to ensure that regulatory device labeling requirements are met for...and/or high complexity products (including combination, Software as a Medical Device , and standalone medical … more
- Medtronic (Memphis, TN)
- …global best practices for OTC in alignment with life sciences/ medical device industry standards, ensuring regulatory compliance . SALES & DISTRIBUTION ... tailored to the unique needs of life sciences and medical device companies, ensuring compliance ,...context. + Familiarity with the regulatory and compliance requirements of the life sciences or medical… more
- Merck (North Wales, PA)
- …post-approval submissions/variations, according to defined timelines. + Provide detailed, global regulatory assessments for changes to device and drug- device ... to existing global guidelines and policies and determine and communicate the regulatory reporting requirements. + Support device design control activities and… more
- Kelly Services (Valencia, CA)
- …inspection readiness activities. * **Product Labeling:** Collaborate cross functionally to ensure compliance with global medical device labeling regulations ... * **Risk Management:** Develop risk mitigation strategies related to regulatory compliance , audits, and product approvals. Lead...a cross-functional matrix environment. * 5+ years Class III Medical Device Company in Regulatory … more
- Fujifilm (Columbus, OH)
- …Keep abreast of new legislation and enforcement matters relevant to the medical device industry as well as industry and compliance best practices. + Perform ... + Bachelor's Degree. + 2 to 3 years of corporate compliance experience in the medical device and/or pharmaceutical industry and working knowledge of… more
- Takeda Pharmaceuticals (Boston, MA)
- …with colleagues in Medical Safety, LOCs, Global Clinical Development, Global Regulatory Affairs, Device Quality, PV Compliance etc. **ACCOUNTABILITIES:** ... + Ensure organizational compliance with relevant medical device legislations and regulations + Prepare,...teams + Monitor and interpret relevant global and local medical device regulatory developments, assessing… more
- Organon & Co. (Jersey City, NJ)
- …Activities will include developing, documenting, and review of documentation to ensure compliance with applicable Medical Device Regulations and internal ... Organon requirements. Sr. Quality Engineer ( Medical Device /Combo Products) is responsible for program...clinical supply, development, and design transfer qualification. + Ensure compliance with regulatory and Organon requirements. Evaluate… more
Related Job Searches:
Compliance,
Device,
Medical,
Medical Compliance,
Medical Device,
Medical Device Compliance,
Regulatory,
Regulatory Compliance,
Regulatory Compliance Medical,
Regulatory Medical Device