- Meta (New York, NY)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Pentax Medical (Montvale, NJ)
- … and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical ... future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist : + Coordinate with...regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices … more
- IQVIA (New York, NY)
- …data, etc.), HCP engagement by life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would also ... **Manager, Medical Affairs Strategy** **Overview** IQVIA is...diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies as well… more
- embecta (Parsippany, NJ)
- …discipline (eg engineering, bioengineering, biology, chemistry). + 5+ years Regulatory Affairs experience in medical device companies. + Must have ... in both the US and Europe, and related regulatory affairs activities to ensure compliance with...current knowledge of the US and European Medical Device regulations. + Demonstrated success in… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …field. Advanced degree preferred. + Minimum of 5 years Regulatory Affairs experience in medical devices , preferably sterile single-use disposable ... **Job Description Summary** The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and develop **use-related risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** ... Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …a **maker of possible** with us. Reporting directly to the business unit Vice President of Medical Affairs , the Director of Medical Affairs has the ... responsibility to support the VP, Medical Affairs in providing medical , scientific and technical...in clinical investigation and 6 years' experience in the Medical Device /In Vitro Diagnostics or related industry… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … role within the core team, aiding product development, remediation projects, and meeting medical device regulatory needs. + Review, comprehend, and compose ... devices to align with global regulations. + Support regulatory submissions towards EU MDR requirements, including but not... device or pharmaceutical industry (clinical research or medical affairs ) + Experience in medical… more
- embecta (Parsippany, NJ)
- …changes, internal audits, or process improvements. + Ensure documentation adheres to global medical device regulatory requirements, including FDA 21 CFR Part ... workflows to enhance efficiency and compliance. + Collaborate with Quality, Manufacturing, Marketing, Medical Affairs , R&D, and Regulatory Affairs teams… more
- Stryker (New York, NY)
- …of RWE studies in close collaboration with internal stakeholders from Clinical Strategy, Medical Affairs , Regulatory , HEOR, and Commercial + Ensure ... and/or other health data partners to identifyadditionalreal-world data sources for medical device evidence generation. + Ensure quality and performance… more
- Colgate-Palmolive (New York, NY)
- …+ DDS, DMD, or PhD. + Minimum of 10 years of experience in scientific affairs , medical affairs , or a related scientific role within the pharmaceutical, ... range of oral health needs. The Director of Scientific Affairs for Colgate Oral Pharmaceuticals is a pivotal role... medical device , or consumer healthcare industry. +… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …creation, and integration with design control processes. + Collaborate cross-functionally with R&D, Regulatory Affairs , Medical Affairs and Marketing ... ongoing maintenance and improvement of product risk files for medical devices . This role is responsible for...relevant experience **Skills:** + Extensive knowledge of the FDA medical device quality system regulations and international… more
- Veterans Affairs, Veterans Health Administration (Montrose, NY)
- …various reports; and works in various environmental conditions. Regularly inspects the medical center to identify potential occupational health hazards and the need ... officials concerned with implementation and compliance of statutory and regulatory occupational health requirements. Conducts a full and comprehensive industrial… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Bioengineering, Biology, Chemistry). + Minimum of 5 years of Regulatory Affairs experience in medical devices , preferably sterile single-use disposable ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist will represent...Q-Sub), EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical device… more
- Pfizer (New York, NY)
- …industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Affairs + Subject-matter expertise within assigned therapeutic area ... to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Regulatory Affairs more
- Danaher Corporation (New York, NY)
- … regulatory , market access, and post-market). You'll collaborate with clinical, regulatory /quality, R&D, medical affairs , IT/security, and our Operating ... and visualization tools. + Proven experience analyzing RWE/RWD (EHR, claims, registries, device logs) for clinical, regulatory , or market access impact. Travel,… more
- Cordis (New York, NY)
- …key clinical and scientific insights to internal stakeholders-such as Clinical Development, Medical Affairs , and Commercial teams, helping shape strategy and ... and medical information between KOLs, other investigators and the company's Medical Affairs , Marketing and R&D groups. + Propose strategic solutions to… more
- Flywheel Partners (New York, NY)
- …podcasts, learning games and skills development workshops. We partner with pharmaceutical, medical device , and biotech companies to drive enhanced clinical ... are predominantly pharmaceutical sales forces, account managers, clinical educators, and medical affairs . This position provides the opportunity to gain… more
- Edwards Lifesciences (Manhattan, NY)
- …surgery or interventional cardiology are strongly preferred; candidates with other relevant medical device clinical sales support experience will be considered + ... Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. After extensive… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …including Quality Engineering, WW Supplier Quality Assurance, Research and Development, Regulatory Affairs , and additionally to corporate functions, ... or other related discipline + At least 3-5 years of medical device , biologic, pharmaceutical, or diagnostic industry experience. **Knowledge and Skills** +… more