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We are currently looking for an ONSITE Sr./Regulatory Affairs Manager for a leading San Diego area medical device/diagnostic company.. Must be willing to relocate and work fully onsite in San Diego, CA.. Bachelor’s degree in Bioengineering, Biochemistry, Molecular Biology, or related field (Advanced degree preferred).. 8+ years in Regulatory Affairs, with 5+ years in IVD regulatory roles.. · Full support and career-development resources to help you reach your potential
Sr. Regulatory Affairs Specialist. A leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations.. The Senior Regulatory Affairs Specialist is a key member of the Regulatory Affairs team and reports to the Associate Director, Regulatory Affairs.. Additionally, the team works closely with cross-functional departments to support product development, submissions, and post-market surveillance activities.. The Senior Regulatory Specialist is responsible for the coordination and preparation of document packages for regulatory submissions for new and mature products, ensuring alignment and compliance with local, regional, and global registration requirements, as well as company policies.
Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. The Senior Director, Regulatory Affairs is a strategic and operational leader responsible for overseeing regulatory strategy, execution, and compliance across all phases of drug development but with a primary focus on early-stage first-in-human / first-in-class molecules. The Senior Director will lead a team of Regulatory Affairs professionals and serve as the primary liaison with global health authorities, including the FDA, EMA, and Health Canada. Deep knowledge of Health Canada and FDA regulatory frameworks, including CTA and IND processes. Understanding of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.. Pulmonx is looking for a Sr Regulatory Affairs Specialist to join our team supporting all regulatory aspects of our groundbreaking medical devices.. If you enjoy a mix of both tactical and strategic hands-on work with a strong group of Regulatory Affairs experts, please apply!. Stay current with industry trends and best practices in international regulatory affairs.. Minimum of 3-5 years of experience in regulatory affairs, specifically with Class II or Class III medical devices.
The Associate Director of Regulatory Affairs is responsible for managing day-to-day Global Regulatory Affairs activities related to Sentynl’s development and commercial pharmaceutical programs. The Associate Director, Regulatory Affairs will be responsible for supporting regulatory strategy implementation for U.S. and global programs and will work closely with the VP of Regulatory Affairs and Quality to prepare regulatory submissions (authoring, reviewing, timeline planning, etc. Knowledge Experience and in the preparation of regulatory submissions, i.e. US IND, NDA, and EU Marketing Authorization Application (MAA), and other potential global territories preferred. The pay range for the Associate Director Regulatory Affairs will be a base salary of $130k to $200k. Unlimited PTO – based upon our trust of employees to manage their work schedule and mutual agreement between the employee and their manager.
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave. Senior Regulatory Affairs Specialist -Vascular (on-site). Senior Regulatory Affairs Specialist – Vascular (on-site). Regulatory Affairs Manager – Heart Failure (on-site). Regulatory Affairs Manager – Vascular (on-site)
Identify potential regulatory risks and proactively develop mitigation or contingency plans.. 8–12 years of regulatory affairs and pharmaceutical development experience.. Writing/Editing and Strategy/Planning.. Biotechnology Research and Pharmaceutical Manufacturing.. Paid maternity leave
VP or Head of Regulatory & QualityLocation: Bedford, MA (Hybrid, 4 days on site, 1 day remote)Industry: Medical DeviceEmployment Type: Full-time | Competitive Compensation & Benefits.. Backed by a strong platform of portfolio companies, we operate with the agility of a startup and the resources of a well-capitalized organization. ResponsibilitiesLead and execute global regulatory strategies, including 510(k), IDE, and PMA submissions. Proven track record with U.S. and global regulatory submissions, including PMA and 510(k). Gain broad visibility across product development, quality systems, and future growth initiatives.
Functional areas of oversight include: St. Francis Hospital Operating Room, Pre-op and PACU. Ensures the quality of Perioperative patient care in the Operating Room and serves as a role model for professional nursing practice.. At UCSF St. Francis Hospital, our Operating Room and Surgical Services department embodies excellence in surgical care, providing patients with state-of-the-art facilities and a dedicated team of highly skilled professionals.. At UCSF St. Francis Hospital, patient safety and comfort are our top priorities.. UCSF St. Francis Hospital is dedicated to serving our community.. Strong hospital management experience, with progressive and in-depth expertise in patient care services.
Conduct risk management and vulnerability analyses on medical devices and support manufacturer’s cybersecurity strategy development, system testing and evaluation, and verification and validation efforts.. 5-10 years working within information/cyber security/FDA cyber Regulatory required.. Knowledge of threat modeling, penetration testing, cybersecurity research, and knowledge of encryption technologies, ethical hacking, and endpoint security tools is preferred.. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).
A leading manufacturer of institutional cleaning chemicals, equipment, and specialty coatings is seeking a Regulatory Affairs Director to oversee compliance across U.S. and international markets.. Review and approve all product labels and materials for compliance with OSHA, EPA, FDA, DOT, FIFRA, CPSC, VOC, and other applicable standards.. Maintain accurate and up-to-date SDS records, classification codes, and emergency protocols (e.g., Chemtrec).. Manage compliance for REACH, CEPA, NAFTA classifications, DOT container testing, SCAQMD, mill assessments, and EPA registrations.. Extensive experience in regulatory affairs, preferably in chemical or equipment manufacturing
Abode Hospice is seeking a Medical Biller to join our team.. The Billing Specialist is responsible for the accurate and timely completion and submission of Medicare, Medicaid, private payer and patient billing, and accounts receivable tracking and follow-up.. Maintain accurate Medicare and Medicaid billing analysis reports.. Assist with the collection of receivables by monitoring accounts receivables, resubmitting bills to overdue accounts, and alerting the billing manager of seriously overdue accounts.. Perform other specific projects relating to billing, data entry, and computer operations as required
B.Sc. (advanced degree preferred) in Life Sciences (Microbiology, Biology, Chemistry or Pharmacy preferred) or extensive equivalent experience and related training.. Certification in Regulatory Affairs (RAC) and other relevant certifications an asset. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.. Accessibility Policy AmerisourceBergen is committed to fair and accessible employment practices.. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.
Benchmark Therapies, Inc. is currently seeking a Physical Therapist for full time hours at the Albright LIFE Center in Lancaster, PA. The Albright LIFE Center is part of a unique, team-based healthcare network dedicated to supporting adults aged 55 and older throughout the Lancaster area. LIFE (Living Independence for the Elderly) provides a comprehensive approach to care. It covers all Medicare- and Medicaid-approved services, as well as additional services determined necessary by the LIFE interdisciplinary care team. As an alternative to nursing homes or traditional home health services, Albright LIFE Centers offer far more than standard adult day care.
As a Registered Nurse (RN) at UAB Medical West, you will play a crucial role in providing high-quality patient care.. Current and valid Registered Nurse (RN) license in the state of Alabama.. Basic Life Support (BLS) certification or must obtain within 30 days of hire.. Preferred Qualifications: Proficiency in electronic health record (EHR) systems.. Educate patients and their families on health management, disease prevention, and wellness strategies.
Join to apply for the Regulatory Affairs Manager V role at Goldbelt Professional Services. The Regulatory Affairs Manager V shall serve as a liaison between the AJPEO MRAS regulatory office and product leads to ensure DoD-funded regulatory Sponsors developing MCMs are complying with relevant laws, regulations, and current guidance’s.. Collaborate and network with internal/external regulatory professionals and clinicians, as well as investigators and researchers, and other scientific and technical disciplines to maintain current knowledge in the Chemical, Biological, Radiological, and Nuclear (CBRN), Emerging Infectious Disease (EID), and other relevant emerging and re-emerging threat spaces.. Industries Government Administration. Sign in to set job alerts for “Regulatory Affairs Manager” roles.
DEPT: Digital Health & Technology - RESEARCH & EHR PHM. This position is responsible for the governance and maintenance of data platforms that enable research, and for providing analytical support to clinical research teams as they utilize self-service analytics.. The ability to effectively influence within the peer group, and throughout the customer base, including with Digital Health & Technology and operational leadership, is necessary.. Familiarity with clinical research methodology and the FDA regulations governing clinical trials, as well as and understanding of appropriate handling of PHI and security.. Area of study or major: Nursing, Medical Technology, Radiology, Mathematics, Engineering, Biomedical Engineering, Laboratory, Pharmacy, or Medicine
Join MarinHealth, an integrated, independent healthcare system with deep roots throughout the North Bay. With a world-class physician and clinical team, an affiliation with UCSF Health, an ever-expanding network of clinics, and a new state-of-the-art hospital, MarinHealth is growing quickly.. MarinHealth is already realizing the benefits of impressive growth and has consistently earned high praise and accolades, including being Named One of the Top 250 Hospitals Nationwide by Healthgrades, receiving a 5-star Ranking for Overall Hospital Quality from the Centers for Medicare and Medicaid Services, and being named the Best Hospital in San Francisco/Marin by Bay Area Parent, among others.. Marin General Hospital dba MarinHealth Medical Center. 6 months to 1-year experience as a Clinical RN I at MarinHealth Medical Center; or. Integrative Agitation Management (IAM) Required within 30 days of hire
The Infection Prevention Specialist (IPS) is a licensed clinician responsible for supporting the development, implementation, and continuous improvement of Neighborcare Health’s Infection Prevention and Control Program. Ensure alignment with CDC, WA DOH, CMS, OSHA, WAC, APIC, and ADS guidelines. Assure NCH is meeting the Center for Disease Control (CDC), WA State Department of Health (DOH), Association for Dental Safety (ADS), Center for Medicare and Medicaid Services (CMS), Washington Administrative codes (WAC), Occupational Safety and Health administration (OSHA) and Association for Professionals in infection control and epidemiology (APIC Guidelines and recommendations for a healthcare setting including dental services. Collaborate with public health agencies (e.g., Seattle King County Public Health (SKCPH), WA DOH) during infection outbreaks or public health threats (e.g., Ebola, MERS, anthrax). Knowledge of Center for Disease Control (CDC), WA State Department of Health (DOH), Association for Dental Safety (ADS), Center for Medicare and Medicaid Services (CMS), Washington Administrative Codes (WAC).
As an AE, you will be responsible for owning the full sales cycle for mid-market and growth accounts, with a focus on building relationships across Quality, Regulatory Affairs, and Post-Market Surveillance teams. You’re a consultative seller with deep curiosity about your customer’s business and a track record of success in complex sales environments. Top pharmaceutical companies, food manufacturers, medtech companies, and service firms from around the globe rely on Redica Systems to mine and process government inspection, enforcement, and registration data. This enables them to quantify risk signals from their suppliers, identify market opportunities, benchmark against peers, and prepare for the latest inspection trends. Our data and analytics have been cited by major media outlets including MSNBC, The Wall Street Journal (WSJ), and The Boston Globe.