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... responsible for developing, implementing, and maintaining quality and regulatory systems in compliance with FDA, ISO, and other global regulatory standards. This role requires deep experience ... regenerative medicine products. ⬢ Prepare and submit CE mark Technical Files, FDA submissions (510(k), IDE, PMA) and other international regulatory dossiers ...

Company: CPL Healthcare (1 week ago)

... execute regulatory strategies for metabolic disease drug development, ensuring compliance with FDA, EMA, and global regulatory requirements. Drive interactions with regulatory agencies, including ... indications (diabetes, obesity, etc.). Proven track record of successful FDA and EMA interactions drive regulatory approvals. Strong expertise in clinical ...

Company: Page Executive (1 week ago)

... and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington' ... Ensures clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and ...

Company: Neurocrine Biosciences (1 week ago)

... requirements and respond to queries. - Support during audits e.g. BIMO, pharma partner, FDA Position Requirements - MSc in Life Sciences, Biomedical Engineering or similar; or equivalent experience ... Working knowledge of regulatory requirements and industry working practices e.g. FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, CLSI guidance, ...

Company: QIAGEN (1 week 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 (1 week ago)

... analytical procedures for genetic therapy materials and products, ensuring adherence to EU and FDA GMP regulations. This role entails overseeing the end-to-end management of ... Proven ability to manage teams and deliver projects on time. Knowledge of EU and FDA regulations, GMP, and related standards. Strong problem-solving, leadership, and ...

Company: Hobson Prior (1 week ago)

... products and medical device human factors Strong understanding of FDA Guidance, International Standards, and Global Regulations Experience: Wide range of ... FDA submission experience Multidisciplinary perspective in: Device design, User research, Instructional ...

Company: ziprecruiter (1 week ago)

... their Phase 3 program. Work closely with Health Authorities. This includes FDA meetings, teleconferences, and responding to Health Authority inquiries. Oversee all lifecycle maintenance filings ... is a plus. Experience directly interfacing with health authorities in major markets (FDA, EMA, MHRA) is a must. Knowledge of global regulatory guidelines as ...

Company: Dennis Partners (1 week ago)

... . Ensure QMS activities meet internal standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485). Support audit readiness by ... regulated industry (e.g., medical device, biotech, pharma) Understanding of FDA QSR (21 CFR Part 820), ISO 13485, or similar quality system ...

Company: ziprecruiter (1 week ago)

... for you to develop relationships and true partnerships at S+N and with FDA reviewers. You will own the submission, and the questions from the FDA. To achieve this, will require partnering with others in S+N ...

Company: Eagleston Financial Group (1 week ago)

... to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA). Support biological hazards risk analysis activities ... device manufacturing processes, and biocompatibility assessment methodology Basic knowledge of FDA and international medical device regulations/directives and working knowledge of GMP ...

Company: ConvaTec Inc. (1 week ago)

... and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington' ... objectives Performs all responsibilities following the highest ethical standards, including FDA guidelines and best practices for the pharmaceutical/biotech industry Effectively utilizes ...

Company: Neurocrine Biosciences (1 week ago)

... with Veeva or Zinc platforms * Understanding of compliance standards in pharma marketing (ABPI, FDA, EMA etc.)

Company: IT Talent Solutions Job type: contract (1 week ago)

... . Compliance & Quality Ensure adherence to standards including AS9100, ISO13485, ISO9001, ISO14001 and FDA 21CFR820. Lead supplier audits and maintain quality documentation and assessments. Drive continuous ...

Company: SoCode Limited Job type: permanent (1 week ago)

... dossier preparation and submission activities. Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration ...

Company: BioNTech IMFS (1 week ago)

... ability to work independently and deliver results efficiently. Excellent understanding of EU and FDA regulations and industry standards (GMP, GLP, GCP). Proficient in Microsoft Office and other relevant ...

Company: CPL Healthcare (1 week ago)

... and meeting preparation Represent the Company and Biostatistics function in interactions, both in writing and in person, with the FDA, EMA and other Health Authorities. Supports regulatory submission and interaction, i.e, and IND ...

Company: Lisebleijs (1 week ago)

... . Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role: The Manager, Downstream MSAT, is ...

Company: Summit Therapeutics Sub, Inc. (1 week ago)

... / Pharmaceutical space, including leadership experience Thorough understanding of global regulations (FDA, EMA, ICH) and their impact on product development and approval Strong leadership and management ...

Company: Mantell Associates (1 week ago)

... management knowledge to ensure high-quality, predictable project timelines and budgets. Adhering to FDA, ISO, IEC design control procedures, regulations, and standards. Ensuring product reliability ...

Company: Vantive (1 week ago)