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... across functions. Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards. Proven problem-solving skills ...

Company: Cook Medical (1 month ago)

... validation. Ensure that validation activities comply with regulatory requirements (e.g., FDA, EMA, ICH) and industry standards (e.g., GAMP 5). ABOUT YOU ...

Company: Life Science Consultants (LSC) (4 weeks ago)

... manufacturing setting. Strong understanding of regulatory requirements for API production, including FDA and other relevant authorities. Demonstrated expertise in implementing lean manufacturing principles to drive process ...

Company: Barrington James (1 month ago)

... : Solid working knowledge of Quality frameworks/offerings/processes (ISO 9001 / FDA regulations / ). Excellent communicator who can influence stakeholders and collaborate cross-functionally. Strong ...

Company: Lorien Job type: permanent (1 month ago)

... regulations and GPS procedures Responsible and accountable for directing all North American (US FDA, Health Canada) PV inspections and PV audits and provide all aspects ... guidelines worldwide Proficiency with PV vendor management. Experience working with the FDA and other regulatory agencies is preferred. Reasonable Accommodation Vantive is ...

Company: Vantive Health LLC (1 month ago)

... innovation. ·Ensure regulatory compliance with GMP, ISO 13485, MHRA, and FDA requirements, supporting audits and inspections. ·Troubleshoot microbiological issues in manufacturing, product ... teams. ·Strong knowledge of regulatory frameworks (GMP, ISO 13485, FDA, MHRA) and experience supporting audits. ·Excellent problem-solving skills, with ...

Company: CPL Healthcare (1 month ago)

... based research is increasingly desired by pharmaceutical companies due to recent FDA and EMEA initiatives as well as changing requirements from health care payers ( ... track record in assisting clients through the process and all the associated requirements for EMA and FDA registration. Access to other MAPI Group company expertise provides a rich ...

Company: Pharma Search (1 month ago)

... to collaborate with global vendors and cross-functional teams. Experience supporting regulatory submissions for FDA and CE marking. Responsibilities: Conduct research and feasibility trials for sterilisation of new ...

Company: Real Job type: contract (1 month ago)

... medicinal products by the Italian National Regulatory Authority (AIFA) and is compliant with the FDA and EMA regulatory guidelines. Job Description We have several openings for talented and highly motivated EU ...

(1 month ago)

... modern reactive frontend framework Background in medical software or regulated industries (HIPAA, FDA, etc.) Exposure to collaborative multi-user environments, such as CRDT-based or real-time ...

Company: RemoteStar (1 month ago)

... including receipt and oversight of compliance related services for FDA Ltd. Assist FDA Ltd in addressing general and specific compliance matters and with the overall ... and communicate breaches and the resolution/status of issues to senior management in FDA. Facilitate regulatory inquiries and examinations, working in co-ordination with compliance ...

Company: E Fundresearch (1 month ago)

... including receipt and oversight of compliance related services for FDA Ltd. Assist FDA Ltd in addressing general and specific compliance matters and with the overall ... and communicate breaches and the resolution/status of issues to senior management in FDA Facilitate regulatory inquiries and examinations, working in co-ordination with compliance ...

Company: Fidelity Investments (1 month ago)

... strategy with execution in a hands-on leadership role. Serve as primary contact with FDA and other regulatory agencies, leading all communications and meetings. Provide key updates and guidance ... a plus but not required A track record of successful interaction with FDA and other regulatory agencies. EMA, Ex-US or global regulatory experience required ...

Company: Dennis Partners (1 month ago)

... practical experience of Quality Management Systems such as ISO 9001, ISO13485 US FDA Quality System Regulation. Qualified internal auditor. Sound awareness of quality ... issues within a supply chain environment. FDA inspection experienced desirable. Knowledge of processes used to manufacture electronic, electro ...

Company: Optos PLC (1 month ago)

... . Strong commitment to quality, safety and GMP standards. Skills: technician medical device FDA

Company: ICDS Group (1 month ago)

... of the PQS and manufacturing activities with the applicable EU and international regulations e.g. FDA as required. The above list of responsibilities may not be exhaustive, and the post holder will ...

Company: King's College London (1 month ago)

... , INDs, Risk Management Plans). Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals. Develop and implement strategies to minimize ...

Company: Novartis (1 month ago)

... , Rheumatology, or Inflammatory diseases. Experience with US and EU regulatory requirements. Interaction with authorities like EMA or FDA is a plus. Skills and Competencies Board certification in Dermatology and/or Rheumatology is ...

Company: MoonLake Immunotherapeutics (1 month ago)

... 62304. Proven track record in interactions with Notified Bodies and/or Regulatory Authorities, especially the FDA. Knowledge of UK, US and/or EU Data Protection Regulations (i.e. GDPR, DPA ...

Company: ZiO Health (1 month ago)

... , including machine learning and artificial intelligence, to set new industry standards. Recently, the FDA selected RxLogix's PV Surveillance Suite Platform to replace its legacy FAERS ...

Company: RxLogix Corporation (1 month ago)