- Merck & Co. (Rahway, NJ)
- … medical devices and combination products globally.- Experience in design controls, device risk management, medical device , complex combination product ... are the cornerstone of decisions and expectations- Lead technical investigations of medical device and combination product needs for commercial products-… more
- Merck & Co. (Rahway, NJ)
- …development including regulatory submission and approval processes. Including development drug- device combination product or a medical device component ... of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and... Working Groups to ensure full integration of the device development activities with the clinical, regulatory ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.Able to write detailed investigation summary memos ... documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and CDR rules,… more
- Merck & Co. (Rahway, NJ)
- …guidance & standards: 21 CFR Part 421 CFR 82021 CFR 210/ 211EU Medical Device RegulationUSP USP FDA Guidance for Industry, Container Closure Systems ... validation.Comprehensive understanding of drug product development in addition to device development expertise.Strong familiarity with regulatory landscape… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and EMEA Regulatory requirements Experience at a medium to large scale medical device , pharmaceutical or biotechnology process firm in an automation role ... (5) year of direct engineering Pharmaceutical, Biotechnology or other regulatory industries experience preferred Knowledge, Skills, and Abilities: Strong knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …database and data validation programming and/or related work experience in a medical device , biotech, or pharmaceutical company, or similar environment (eg, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred Experience Qualifications4 or more years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Durham, NC)
- …manufacturing, utility &/or packaging systems required, preferably in the pharmaceutical or medical device field Demonstrated expertise in Regulations & quality ... Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes &… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …possess strong knowledge manufacturing within a regulated industry such as medical device , automotive, or defense.Must be detail-oriented with exceptional ... of user requirements and ensure they conform with company processes and regulatory guidance.Critical process parameter (CPP/CQA) - assure CPP/CQAs are defined and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …more than 3 year of experience.Engineering experience in the Pharmaceutical, Biotech or Medical Device industries.Experience in WFI and HVAC systems, clean and ... is maintained to meet GMP requirements.Support utilities areas in Regulatory / FDA inspections ensuring successful outcomes.Cross functional collaboration with… more
- Lundbeck (Plano, TX)
- …from an accredited college or university 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Lundbeck (Chicago, IL)
- …5+ years of Specialty Sales experience in Pharmaceutical, Biopharmaceutical, Biologics or Medical Device sales experience Ownership and accountability for the ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations… more
- Lundbeck (Nyack, NY)
- …from an accredited college or university 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Cytiva (Miami, FL)
- …Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device , Biopharma, or other FDA or EPA-regulated ... Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management… more
- LCI-Lawinger Consulting (Minneapolis, MN)
- …team, you will play a critical role in ensuring the safety, effectiveness, and regulatory compliance of medical device products. Key Responsibilities: + Lead ... 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
- Actalent (Davis, CA)
- Job Title: Regulatory Specialist Job Description The Regulatory Specialist is responsible for the implementation and oversight of compliance and operational ... efficiencies within the Quality and Regulatory Department. This position reports to the VP of...submissions or internal documentation that are required for proposed device changes or labeling changes. + Identify relevant guidance… more
- Astrix Technology (Fairfield, CT)
- …+ **Compliance & Safety:** Ensure all designs comply with safety, quality, and regulatory standards, particularly for medical device development. Define and ... **Mechanical Engineer - Medical Device ** Engineering Fairfield County, CT, US Pay Rate Low: 130,000 | Pay Rate High: 155,000 + Added - 06/03/2025 Apply for Job… more
- Fujifilm (Salt Lake City, UT)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... **Position Overview** This position is intended to sell Fujifilm medical imaging devices, options, and service contracts to prospective and existing customers in… more
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