- Merck & Co. (Rahway, NJ)
- …including regulatory submission and approval processes.Has broad knowledge of medical device development, design controls and risk managementKnowledge of US ... their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on… more
- Sun Pharma (Taro Pharma) (Billerica, MA)
- …following FDA and ISO regulations.directly on technical investigations relating to medical device Quality Complaints.verbal and written responses/resolutions ... 820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282).Experience in leading and/or supporting medical device regulatory inspections by FDA and Health Canada,… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …and payers. Discuss operational issues and reviews records/documentation to ensure regulatory and in-house compliance. Assists with Device Clinic research ... providing reports for the EP Physicians and the patient medical record. Participates in clinical research as job requires....on the job training and demonstrated proficiency in Cardiac Device Management may be substituted for the formal education… more
- Merck & Co. (Rahway, NJ)
- … activities with cross- product or cross-functional impact, including drug device /combination products and software-as- medical device platforms.- Reviews ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- Arthrex (Ave Maria, FL)
- … Quality Control or Quality Assurance position in a Medical Device Company preferred. Knowledge and Skill Requirements/Specialized Courses and/or ... Arthrex, Inc. is a global medical device company and a leader...orthopedics. Arthrex is actively searching for an Engineer I Quality Systems and Regulatory Compliance for our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and submission plans), including HA engagement plans and mitigation strategies.Ensure high quality collaboration global regulatory leads and provides guidance to ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed to achieve the full potential of the organization to deliver pharmaceutical and medical device products to patients with unmet medical needs and ... healthcare environment required.Must have experience working within Bio, Pharma, Medical Device , Vaccines, Diagnostics, Combinations Products, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Experience Level: 7+ years of relevant experience Minimum of 5 years clinical/ regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO ... Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and Non-clinical Development.… more
- Catalent (St. Petersburg, FL)
- …years auditing experience Experience working in an auditing role within the Pharmaceutical/ Medical Device industry, required Knowledge and understanding of the ... of existing and prospective suppliers in compliance with Global procedures and Regulatory requirements Generate Global Quality Agreements in accordance with… more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... Better (TM) . We are committed to delivering uncompromising quality to the health care professionals who use our...a major metropolitan airport **Arthrex, Inc. is a global medical device company and a leader in… more
- Arthrex (Goleta, CA)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... Better (TM) . We are committed to delivering uncompromising quality to the health care professionals who use our...other status protected by law.Arthrex, Inc. is a global medical device company and a leader in… more
- Mid Michigan Health (Midland, MI)
- …patients. This position is responsible for coordinating care to assure high quality , compassionate patient care is provided. They will maintain and oversee patients ... other organizations and departments. This position may be required to order all medical , pharmacy supplies, and office supplies to manage patient care. They will… more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... Better (TM) . We are committed to delivering uncompromising quality to the health care professionals who use our...other status protected by law.Arthrex, Inc. is a global medical device company leader in new product… more
- Arthrex (Ave Maria, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... Better (TM) . We are committed to delivering uncompromising quality to the health care professionals who use our...other status protected by law.Arthrex, Inc. is a global medical device company and a leader in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic ... collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to...data management and/or related industry work experience in a medical device , pharmaceutical company, or similar environment… more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... Better (TM) . We are committed to delivering uncompromising quality to the health care professionals who use our...other status protected by law.Arthrex, Inc. is a global medical device company and a leader in… more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... Better (TM) . We are committed to delivering uncompromising quality to the health care professionals who use our...other status protected by law.Arthrex, Inc. is a global medical device company leader in new product… more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... Better (TM) . We are committed to delivering uncompromising quality to the health care professionals who use our...other status protected by law.Arthrex, Inc. is a global medical device company and a leader in… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.Able to write detailed investigation summary memos ... accuracy of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred Experience Qualifications4 or More Years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug ... Quality Management System and GMP Compliance Programs to assure product quality , integrity and compliance with regulatory guidelines and internal/global… more
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