- Sanofi Group (Cambridge, MA)
- …GRA Device representative in project/product teams + Develop innovative and sustainable medical device regulatory strategies + Provide regulatory ... **Job Title:** Global Regulatory Affairs Device Head ,...be key deliverables. **Knowledge:** + Proven experience in global medical devices regulatory for drug-led… more
- J&J Family of Companies (Raritan, NJ)
- …R&D teams (inclusive of indirect or direct reports) + Understanding of Global Regulatory /Clinical requirements of complex medical devices + Strong technical ... Chain, Quality and Finance. The role also requires strong technical expertise in medical device development including a strong understanding of global … more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... Care Combination Products, who in turn reports to the Head of GRA Device . The candidate will...to internal regulatory processes and procedures for medical devices and combination products. + Engage… more
- Aerotek (Irvine, CA)
- **Cleanroom Operator** + This position is responsible for the production of high-quality medical devices within a manufacturing cell. + Working under close ... test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. + The role requires spending 95% of… more
- Sanofi Group (Framingham, MA)
- …with a minimum of 15 years relevant experience in the pharmaceutical, biotech, medical device , or related industries. + Extensive knowledge of Quality Systems ... **Job Title:** Compliance Head - US FDA **Location** : Framingham, MA, Morristown,...secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity,… more
- CIBC (Chicago, IL)
- …please visit CIBC.com (https://www.cibc.com/en/about-cibc.html) **What you'll be doing** The Head of US End User Technology Infrastructure Engineering will lead ... employees, enabling productivity and collaboration while maintaining compliance with regulatory requirements. You'll develop and execute the end-user technology… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …true value to patients, healthcare providers, payers, and other stakeholders. The Head of R&D Data and Quantitative Sciences reports directly to the President ... dynamic needs of our global project teams. + The Head of R&D Data & Quantitative Sciences will lead...predictive, prescriptive, and real-time analytics as well as novel devices and artificial intelligence. + Oversee the development of… more
- Haleon (Warren, NJ)
- … classifications. North America has more than 300 formulations across medicinal, medical devices , cosmetics and dietary supplements. + Accountable for the ... are at the forefront of biopharmaceutical technology? If so, this Regional Technical Head role could be an exciting opportunity to explore. As a Regional Technical… more
- McAfee, Inc. (San Jose, CA)
- **_Job Title:_** Global Head of Privacy Legal **_Role Overview:_** The Sr Director, Global Head of Privacy Legal role is an exciting opportunity for a passionate ... template agreements, and other foundational resources to promote compliance with evolving regulatory requirements in the US and globally + Develop and conduct… more
- Truist (Richmond, VA)
- …will have deep expertise in vulnerability lifecycle management, risk-based prioritization, regulatory compliance (eg, FFIEC, OCC, SOX, PCI-DSS), and automation to ... management processes with FFIEC, OCC, GLBA, NIST, SOX, and PCI-DSS regulatory requirements. Collaborate with risk management, audit, and compliance teams to… more
- Amazon (Seattle, WA)
- …oriented Product Compliance leader to lead the compliance engineering strategy and global regulatory vision for AWS's hardware products. This role will manage a team ... requirements globally - Evaluating and mitigating product design and global regulatory risks related to safety, EMC, energy efficiency restricted substances, and… more
- Ascendis Pharma (Palo Alto, CA)
- …Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team. This role involves ... regulatory affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory experience including IND/CTA,… more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… more
- Bayer (NJ)
- …and priorities of the Country Divisional Heads as well as those of the Global Regulatory Head and R&D organization. Inspires and trains US regulatory staff, ... optimal labels; + Leads alignment with US Market Access, Medical Affairs and Commercial to enable regulatory ...who possesses the following: **Required Qualifications:** + US FDA regulatory experience in related drug or device … more
- BeOne Medicines (San Mateo, CA)
- …formulation, analytical, manufacturing, QC, QA, etc.). * Experience in gene/cell therapy or/and medical device is a plus. * In-depth knowledge of ICH ... The individual manages direct reports of 10+ and reports to global head of regulatory CMC. **Essential Functions of the job:** * Lead, develop, and optimize… more
- Sanofi Group (Cambridge, MA)
- …responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record ... and direct reports. + In conjunction with the Sr. Director/Product Support Head , imparts senior regulatory guidance and advice during issues management… more
- Knowles Precision Devices (New Bedford, MA)
- …and within quality standards and cost objectives. REPORTS TO: Head of Manufacturing SUBORDINATES: Manufacturing sections involving skilled machine operators, ... Maintain compliance of company policies, safety standards, quality specifications, regulatory requirements, and sanitation practices. + Drive continuous improvement… more
- Abbott (Hartford, CT)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... hospital management to sell a variety of Abbott USD medical devices in an assigned territory. May...* Working knowledge of domestic regulations relative to the medical device industry. * A demonstrated ability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **JOB SUMMARY** The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... or equivalent experience from any of these industries: Pharmaceuticals, biologics, Medical Device , Vaccines, Diagnostics, Generics/ Consumer products +… more
- University of Colorado (Aurora, CO)
- …Associate Chief Medical Officers (ACMOs), relevant Department Chair (or Division Head , as appropriate) and concurrence from the UCH CNO (or designee) and/or UCH ... Associate Chief Medical Officers (ACMOs), relevant Department Chair (or Division Head , as appropriate) and concurrence from the UCH CNO (or designee) and/or UCH… more
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