- 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
- Cytiva (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the Business ... and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change control, and in… more
- Aldevron (Miami, FL)
- …and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align ... with regulatory requirements and company branding.In this role, you will...maintain labeling integrity.Collaborate with internal stakeholders: Work closely with Regulatory Affairs, Quality Assurance, and Manufacturing teams to ensure… more
- Cytiva (Pensacola, FL)
- …site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management ... with senior leadership roles in QA, Operations, or Quality Engineering preferred. Regulatory and Quality Expertise: Strong knowledge of ISO standards, FDA… more
- Aldevron (Miami, FL)
- …Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic ... as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality AgreementsDevelop and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …Device Regulation (IVDR) as well as all other applicable global regulatory requirements.Maintain oversight, tracking, metric reporting and escalation of issues while ... and requests for information to FDA, MDSAP Notified Body and other Regulatory Bodies.Utilize Danaher Business System (DBS) tools to drive compliance, effective… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …support of the stability program, including review and implementation of regulatory requirements for the stability program.Coordinate with Quality Control management ... the creation, review and trending of data, to meet customer, industry and regulatory requirements and presenting data in graphical form and reports provided to… 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 ... at Aldevron are qualified/validated in accordance with the appropriate current regulatory expectations, in a phase-appropriate manner. Aldevron is seeking a highly… more
- Cytiva (Miami, FL)
- …providing quality leadership in manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading root cause analysis ... Quality Leader and is part of the Quality and Regulatory Affairs Team located in Shrewsbury, MA. and will...related field.Minimum 5 years of experience in Quality or Regulatory in a regulated industry (ISO 9001, medical device,… more
- Cytiva (Miami, FL)
- …to increase production capacity and improve process performance ensuring compliance with regulatory requirements (eg, FDA, ISO, PSM) and contribute to audits and ... in healthcare manufacturing or medical device production.2+ years experience with regulatory standards and quality systems (eg, FDA, ISO 13485, Good Manufacturing… more
