- LSI Solutions (Victor, NY)
- …to gather regulatory intelligence regarding updates to US and international medical device regulations, and supporting Rest-of-World (ROW) regulatory ... govern the design, development, manufacturing, and distribution of our medical devices . REPORTS TO: REGULATORY ... medical records. + A rudimentary understanding of Regulatory principles that govern medical device… more
- Fujifilm (Albany, NY)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...The Senior Counsel, reporting to the Division General Counsel, Medical Devices , will be an experienced commercial… more
- Merck (Albany, NY)
- …& Technology Team, with responsibilities supporting the commercialization and sustainment of medical devices and combination products globally. * Experience in ... design controls, device risk management, medical device ,...experience to develop value-add solutions to customer needs in medical devices and combination products * Secure… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …development lifecycle of an off the shelf, or an internally designed platform medical device delivery system. + Defines detailed product requirements and ... equivalent combination of education and experience Previous experience in combination product/ medical device development or similar area is required. Experience… more
- Albany Medical Center (Albany, NY)
- …healthcare reimbursement systems and regulatory requirements + Familiarity with medical devices , pharmaceuticals, or healthcare technologies + Project and ... and Value Analysis, this position is responsible for evaluating medical products, services, and technologies to optimize cost-effectiveness while maintaining… more
- WMCHealth (Warwick, NY)
- …within the facility to maintain accurate and orderly records meeting the regulatory requirements. Responsibilities: Medical Records + Manage Medical ... release of record, conferring with legal departments. + Oversees the release of Medical Records to other providers, regulatory agencies, billing agencies, and… more
- TD Bank (New York, NY)
- …economic information, and key industry developments, as well as internal policies and regulatory standards (as communicated by Compliance) at all times to assist in ... lines, corporate, and/or control functions and ensures alignment with enterprise and/or regulatory requirements + Maintains a culture of risk management and control,… more
- Grifols Shared Services North America, Inc (Manhattan, NY)
- …regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides ... submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- ThermoFisher Scientific (Rochester, NY)
- …least 2 years of experience in a regulated industry (pharmaceutical or medical device ). **Preferred Qualifications** + Familiarity with product stewardship, ... regulations (EU REACH, CA Prop 65, TSCA). + Understanding of pharmaceutical and medical device standards and regulations (USP, ISO 10993, ISO 13485, IVDR,… more
- United Therapeutics (Albany, NY)
- …), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee… more
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