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Job DescriptionThe Patient Care Technician (PCT) reports to the Nurse Manager.. Under the direct supervision of a Registered Nurse, the PCT performs multi-skilled activities to support a decentralized patient-centered approach to patient care and achieve desired outcomes.. Experience: One year of patient care work experience in a health care facility, Certified Nursing Assistant, EMT or Paramedic certification, Bachelor’s Degree or enrollment in a healthcare related program with successful completion of a Nursing Assistant, Medical Assistant, or Nursing Fundamentals course at an accredited institution or equivalent training preferred.. Current American Heart Association (AHA) Basic Life Support (BLS) certification or American Red Cross BLS for Healthcare Providers certification is required.. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations.
The Vice President, Regulatory Affairs is responsible for developing and directing Partner Therapeutics’ (“PTx”) regulatory strategy, objectives, policies, and programs from IND planning through NDA and future commercialization.. This role will also drive the operational aspects of regulatory compliance and submissions for all programs including CMC, discovery, preclinical, and clinical as well as for all post-approval obligations.. Identifies regulatory operations or processes in need of improvement and leads the development and implementation of appropriate improvements.. Software application experience with Smartsheet, MS Project, and SharePoint.. Extensive experience in cGMP and other Regulatory (CMC, preclinical) compliance requirements.
In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program(s) under your accountability. By joining our growing and dynamic regulatory affairs team, you’ll be responsible for the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. 8+ years of Regulatory Affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development – both big and small company experience is preferred.. Demonstrated experience with regulatory programs for products to treat rare diseases and/or unmet medical needs (e.g., orphan products, fast track, breakthrough therapies, PRIME).. Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box; preference for demonstration of such within rare disease programs
Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond. This role is responsible for the development and execution of regulatory strategy across all functions, including preclinical and clinical development, CMC, and eventual commercialization. Partner with internal stakeholders (R&D, CMC, Clinical Operations, Corporate Strategy, Legal, etc. Minimum of 15 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including at least 8 years in leadership roles. Deep understanding of regulatory guidance, quality standards (GxPs), and global health authority expectations across therapeutic modalities, with emphasis on RNA, lipid nanoparticle, gene, or cell therapy platforms.
Director of Regulatory Affairs (San Francisco, CA).. Oversee the preparation, review, and submission of regulatory documents, including INDs and FDA submissions. Guide project teams in interpreting and communicating regulatory requirements. Education: BA/BS degree in biological or physical sciences preferred. Proficient in MS Office and experience with document management systems.
Provide input/expert review of regulatory submissions as required (e.g. CTA/IND, Orphan Drug Designations/Fast Track/Breakthrough Designations NDA/MAAs). 20+ years experience in global regulatory affairs, including hands on preparing/writing/submitting of at least one NDA or MAA and management of post-approval regulatory activities. Global Regulatory Affairs Chief of Staff. Special Agent: Healthcare Services /Medical Background. Senior Corporate Compliance Manager - Training, Communications & Policy (Remote)
Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules. Lead and Manage Global Submission Activities: Oversee submission planning, authoring, reviewing, and coordination for regulatory filings (e.g., BLA, MAA). Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance documents. Master Degree (MS/MA) Science degree (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) - Required.. Substantial knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements.
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)
Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the team's activities from IND-enabling studies and first-in-human (FIH) studies through clinical proof of concept (PoC) trials, and to facilitate post-PoC transitioning to our Otsuka affiliate for global clinical development & commercialization.. Effectively negotiate alignment with Otsuka parent and affiliate organizations on strategy & messaging to produce optimal outcomes from global health authority interactions.. Define and oversee phase-appropriate CMC regulatory strategy for biologics, including CMC regulatory-specific risk mitigation, and ensuring seamless progression from discovery through early clinical development.. Support CMC functions (e.g. Process Development, Analytical Development, Manufacturing and Quality Control) pertaining to the preparation and content of CTA/IMPDs, PPQs, INDs dossiers to ensure timely delivery of final documents to be included in submissions.. 15+ years of global regulatory affairs experience, including at least 5 - 7 years in biologics, with expertise in early-stage development (IND-enabling, FIH, PoC), CMC regulatory strategy, and global compliance.
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).
Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS).. Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.. The Senior Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs.. This role is based in Waltham, MA without the possibility of being fully remote.. Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc).
We are partnering with a well established Biotech company here in the SF Bay Area as they search for their next Associate Director of Regulatory Affairs. Oversee the planning, preparation, and submission of regulatory documents to global health authorities (e.g., FDA, EMA), including INDs, CTAs, DMFs, BLAs, and MAAs. Partner with regulatory operations to build and maintain submission timelines and global regulatory plans. Bachelors degree in Life or Health Sciences required; advanced degree (MS, PhD, PharmD) strongly preferred. 810 years of industry experience in pharmaceuticals or biotechnology, with a minimum of 46 years in regulatory affairs.
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!. Location: Remote (or hybrid opportunity in the Bay Area if you prefer!). 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.
Their reach is global and they are the industry leader in their specialty, with a second location in Asia. The investment into R&D is significant with several products in the pipeline at various stages and their financial standings are strong.. The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed.. Assess regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization, or packaging and notify regulatory agencies and NB of substantial changes.. 5-10 years experience in regulatory affairs within the medical device industry. Authoring experience in FDA product submissions (IDE, PMA, 510k)
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
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
Senior Regulatory Affairs Specialist (Finance). The Senior Regulatory Affairs Specialist responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified Class I, II, III and IV medical devices in specific markets.. In addition to submissions, the Regulatory Affairs Specialist will serve as a communication liaison between the Cook manufacturer and the Cook Local Office / Cook Distributor.. Communicate Country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assist with the regulatory strategies.. Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies.
Join to apply for the Regulatory Affairs Specialist, Senior role at Nemours. Nemours is seeking a Regulatory Affairs Specialist, Senior to join our Nemours Children’s Health team in Wilmington, DE. This is a hybrid position.. The Senior Regulatory Affairs Specialist is responsible for the successful implementation of regulatory goals and objectives.. Leads annual Intracycle monitoring (ICM).. Sign in to set job alerts for “Senior Regulatory Affairs Specialist” roles.
Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond.. This role is responsible for the development and execution of regulatory strategy across all functions, including preclinical and clinical development, CMC, and eventual commercialization.. Partner with internal stakeholders (R&D, CMC, Clinical Operations, Corporate Strategy, Legal, etc.). Minimum of 15 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including at least 8 years in leadership roles.. Deep understanding of regulatory guidance, quality standards (GxPs), and global health authority expectations across therapeutic modalities, with emphasis on RNA, lipid nanoparticle, gene, or cell therapy platforms.
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.