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... 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 day ago)

... of emerging regulatory practices, expectations and engagements outside of the US FDA and EMA In addition, take on other leadership responsibilities as needed, including: Member ... research, including COA science, preference research, and regulatory engagement (US FDA essential, EMA and other regulatory agencies desirable) Experience working in ...

Company: IQVIA (2 days ago)

... and reporting. Understanding of validation principles and testing procedures. Knowledge of FDA, ISO, RAC, and CQA regulations and standards. Willingness to travel internationally (15 ... Systems). Minimum 5 years conducting quality audits. Experience with FDA and regulatory inspections. In-depth knowledge of quality management systems and global ...

Company: Celestica Ireland (1 day ago)

... continuously improve the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant standards. Lead internal ... Quality and Regulatory roles within the medical device industry. Proven expertise with ISO 13485, FDA QSR, EU MDR, and global submission processes. Demonstrated ability to build and scale ...

Company: Wallace Myers International (2 days ago)

... to the care and use of laboratory animals. Knowledge of GLP regulations and other FDA regulations applicable to non-clinical testing programs. Excellent organizational skills and the ability ... in 21 countries and have worked on over 80% of the FDA-approved drugs over the last five years and 85% of FDA-approved drugs in 2023 alone. As a partner of ...

Company: American Society for Clinical Laboratory Science (2 days ago)

... the Electronic Quality Management System (eQMS), ensuring compliance with ISO 13485, FDA 21 CFR Part 820 (QMSR), MDSAP, and other applicable regulations. Identify ... international quality regulations and standards, with practical experience in ISO 13485, MDSAP, and/or FDA 21 CFR Part 820. Strong communication and interpersonal skills with the ability ...

Company: ziprecruiter (2 days ago)

... technologies meet quality standards, including ISO, FDA, and CE markings. 2. Ensure compliance with regulatory requirements, including FDA, CE, and ISO regulations. 3. Develop and implement ...

Company: Novintix Technologies Limited (2 days ago)

... team members, supporting talent growth and performance excellence. Ensure compliance with FDA, ISO, and Stryker corporate quality standards during product introduction. What ... experience leading and developing teams. Preferred Qualifications: In-depth knowledge of FDA regulations, ISO standards, and experience managing regulatory inspections/audits ...

Company: Stryker Ireland (2 days ago)

... Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR 820 & 803, ISO 13485, ISO ... industry. Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QSRs is required. Experience in management of Quality Systems activities, in particular ...

Company: Life Science Recruitment Ltd (2 days ago)

... safety, environmental standards, and relevant authority guidelines (e.g., VMD, MHRA, FDA). Promote and enforce safe working practices for all personnel, including engineering and maintenance ... functional teams. In-depth knowledge of regulatory standards (e.g., GMP, FDA, EMA, VMD) and validation processes. Strong leadership and people management Deep ...

Company: Norbrook (2 days ago)

... operations and contract manufacturing to ensure product quality, compliance with ISO 13485 / FDA 21 CFR 820, and readiness for regulatory inspections. Key Responsibilities: Oversee ... quality within a regulated industry Strong knowledge of ISO 13485, FDA QSR, and process validation Experience supporting regulatory audits or working with Regulatory ...

Company: Reperio Human Capital Ltd (1 day ago)

... risk assessments. Ensure all validation activities comply with regulatory standards such as GxP, FDA 21 CFR Part 11, and EMA guidelines Prepare validation summaries, deviation ... preferably in a pharmaceutical or regulated environment. In-depth knowledge of GxP regulations, FDA 21 CFR Part 11, and other relevant standards. Experience with validation of ...

Company: Catalyx (1 day ago)

... essary repairs or adjustments. Ensure all calibration activities comply with ISO 13485, FDA regulations (21 CFR Part 820), and other applicable standards. Develop and update ... standards. Proficiency in using calibration software and equipment. Familiarity with ISO 13485, FDA regulations (21 CFR Part 820), and other relevant standards. Excellent ...

Company: Celestica Ireland (1 day ago)

... Engineering Lead About Sanmina Fermoy Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO for the manufacture of high-quality PCBAs ... improvement initiatives. Identifies, plans, and organizes regulatory affairs for ensuring compliance with the FDA's Quality System Regulations, ISO 9000, ISO , JPAL as well as all international ...

Company: Sanmina (1 day ago)

... knowledge of federal, state, and local regulations (e.g., GDPR), including FDA, EMA, and WHO guides on data integrity You have proven technical writing ... Data Governance Specialist : 8+ years of professional experience or equivalent in pharmaceutical/FDA-regulated environments such as data management, quality assurance, compliance, manufacturing ...

Company: Regeneron Ireland DAC (1 day ago)

... facilities in 21 countries and have worked on over 80% of the FDA-approved drugs over the last five years and 85% of FDA-approved drugs in 2023 alone. As a partner of ...

Company: American Society for Clinical Laboratory Science (6 days ago)

... Key Knowledge Knowledgeable of regulations driving the core business (e.g. FDA, EMA, MHRA) Expertise within their assigned process Expertise in systems supporting ... a minimum 10 years of experience within pharmaceutical industry (with GMP knowledge; FDA, EMA, MHRA) and IT systems including: Experience with implementation and/or change management of ...

Company: Fujifilm UK (6 days ago)

... Writer working in a CRO or Pharma. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. - Demonstrated ... Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across ...

Company: Syneos Health Careers Job type: temporary (6 days ago)

... just submitted dual 510(k) CLIA waiver applications to the U.S. FDA. This means you will be an important part of a high ... option to acquire the company up to or shortly after 510(k) clearance by the FDA. In QuidelOrtho, we have an investment partner that recognises the capabilities of our team ...

Company: LEX Diagnostics (2 days ago)

... relevant scientific and/or medical knowledge and expertise. - Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. - Demonstrated ... Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across ...

Company: Syneos Health Careers (2 days ago)