- Merck & Co. (Rahway, NJ)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... Building, Human Resource Management, Immunoassays, Immunology, Immunotherapy, Management Process, Medical Devices , Mentoring Staff, Ophthalmology, Pathophysiology, People… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with start-ups, technology companies, and other external partners across diagnostics, medical devices , digital health, digital therapeutics, and data analytics ... innovations and emerging technologies, including diagnostics, data, digital health solutions, medical devices , and precision health Global Partnership Influence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for Novo Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes medical treatments, customer solutions, and devices across multiple Therapy Areas ... Bleeding Disorders. Relationships This role reports to the Commercial Strategy and Marketing Head and is a key contributor to the Rare Disease Marketing team.… more
- Aptar Group (Orlando, FL)
- …products, and related disposables, IFU's and packaging. Existing knowledge of pharmaceutical and medical device development regulatory classes, and region to ... such as, Device Engineers, Usability Experts, HF Engineers, Regulatory Affairs, Marketing/Brand Managers, Commercial teams, Medical /Clinical Affairs, Market… more
- Capstan (Santa Cruz, CA)
- Reports to: Head of Regulatory Affairs (SVP, RA) Workplace...degree is a plus. Minimum of 8 years of regulatory experience in the medical device ... regulatory activities. Skills: Experience in Class 3 implantable devices , cardiovascular implants is strongly preferred. Ability to work collaboratively in… more
- Universal Healthcare Resources (Sterling Heights, MI)
- …clinicians. Our unique perspective combines superior knowledge of the healthcare regulatory industry with a passion for positive patient outcomes. We incorporate ... the Occupational Therapist Assistant. Provides documentation to maintain quality of the medical record as it relates to accuracy, continuity of care and… more
- Cedent (Bastrop, TX)
- …law, or other applicable degree. 4+ years' pharmaceutical manufacturing, laboratory, or medical device experience, with knowledge of controlled substance and ... The Site Compliance Manager combines expertise in operations, training, and regulatory oversight to oversee regulatory compliance within our facility. This role… more
- City of Tracy, CA (Tracy, CA)
- …Develop innovative fire prevention solutions that meet code and regulatory requirements while providing customers with reasonable, obtainable expectations. ... check, and criminal history review. TOOLS AND EQUIPMENT Emergency medical and fire apparatus, radio, pager, personal computer, phone....have hearing sufficient to test alarms and other auditory devices . Must be able to coordinate more than one… more
- Abbott (Alameda, CA)
- …a robust, scalable digital QMS tailored for Software as a Medical Device (SaMD) in a regulated environment. + Regulatory Strategy: Develop and execute ... Quality Assurance and Compliance system optimized for Software as Medical Device . In addition, this individual will...MDR/IVDR. + Successful track record of preparing and submitting regulatory dossiers for medical devices ,… 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
- Merck (Boston, MA)
- …cross-functional impact, including drug device /combination products and software as medical device platforms. Reviews and resolves issues that span diverse ... Building, Human Resource Management, Immunoassays, Immunology, Immunotherapy, Management Process, Medical Devices , Mentoring Staff, Ophthalmology, Pathophysiology, People… 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
- J&J Family of Companies (Jacksonville, FL)
- …is required. + Industry experience leading Clinical/R&D teams in a highly regulated, commercial medical device business is required. + A minimum of 8 years ... evidence generation for new and existing products to support innovation, regulatory approval/clearance, health technology assessment, customer access, medical … 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
- AbbVie (Irvine, CA)
- …Qualifications and Experiences: + 15+ years' experience in the pharmaceutical and/or medical device industry in progressive commercial leadership roles with a ... finance, market research, clinical training, market analytics and competitive intelligence, regulatory , reimbursement, medical , R&D and clinical trials, product… more
- Truist (Dallas, TX)
- …(United States of America) **Please review the following job description:** The Head of Observability and Monitoring will lead the strategy, architecture, and ... skills to drive best-in-class monitoring solutions that align with regulatory and business requirements. **ESSENTIAL DUTIES AND RESPONSIBILITIES** **Technical… more
- Sanofi Group (Morristown, NJ)
- …or PhD in LifeScience; Law or Computer Sciences + **Pharmaceutical, biotech, medical device industry experience required** + Demonstrated experience in working ... **Job Title:** Head of Privacy, SpeCare and North America **Location:**...generate deeper insights to our Research, Marketing, commercial and medical activities. + Actively monitor North American privacy regulations/enforcements,… 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
