Regulatory Affairs Specialist IV JouléRegulatory Affairs Specialist IVMountain View, CA$60 / hourMinimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). • Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation and regulatory submissions.
Senior Regulatory Affairs Specialist Iovance Biotherapeutics IncSenior Regulatory Affairs SpecialistSan Carlos, CARemote$140,000–$160,000 / yearWorks with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Public Affairs Specialist - City Manager's Office (Communications & Legislative Affairs Office) City of FremontPublic Affairs Specialist - City Manager's Office (Communications & Legislative Affairs Office)Fremont, CA$91,256.65–$110,923.06 / yearAbility to: Prepare and present clear, concise, and accurate oral and written reports, statements, speeches, talking points, and presentations; plan, organize, and implement duties and responsibilities defined by desired outcomes and objectives; develop and implement projects and processes designed to enhance community relations at the block, neighborhood and city-wide level; develop and maintain effective working relationships with individuals from a variety of ethnic and socio-economic backgrounds; observe a variety of problems, identify core issues, and participate in the development of plans to address core issues; work cooperatively with other City departments and other agencies to leverage the use of community resources; plan, organize, and conduct large and small public meetings; develop and maintain cooperative relationships with neighborhood and community groups and City staff; facilitate problem solving among different parties with varying interests; respond to and effectively prioritize multiple requests for service; work irregular duty hours, nights, evenings, weekends and some holidays as required. Knowledge of: Principles, practices, and methods of various forms of mass media including but not limited to Internet, social media, print, television and radio, electronic communications and community engagement programs; problem solving techniques, working with graphic design software and digital media tools, writing, editing and techniques of team building, conflict resolution techniques, processes used in collaborative decision making, consensus building, and meeting facilitation; communication principles and practices; crime prevention principles and practices; emergency management training programs; fire safety, emergency preparedness and community organizations and agencies.
Director, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteSan Francisco, CARemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
Regulatory Affairs Specialist AbbottRegulatory Affairs SpecialistPleasanton, California$73,900–$116,000 / yearAt Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis tomonitoringand treatment. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesRegulatory Affairs Specialist - Vascular (on-site)Santa Clara, CA$81,500–$141,300 / yearOur extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities.
Strategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsMountain View, CA10 years of experience in management consulting, operations, business strategy, regulatory, legal or corporate advisory, or 8 years of experience with an advanced degree. Advise Regulatory Affairs leadership on critical OKRs, business plans, and operating plans while defining change management strategies to implement new initiatives.
NewSenior Regulatory Affairs Specialist Intuitive Surgical IncSenior Regulatory Affairs SpecialistSunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Principal Regulatory Affairs Specialist Procept Biorobotics CorpPrincipal Regulatory Affairs SpecialistSan Jose, CAIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. What Your Day-To-Day Will Involve: Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT's products, marketing applications and post-market activities.
Senior Regulatory Affairs Specialist - Lingo (on-site) Abbott LaboratoriesSenior Regulatory Affairs Specialist - Lingo (on-site)Alameda, CA$90,000–$180,000 / yearIn this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
Principal Regulatory Affairs Specialist Procept BioroboticsPrincipal Regulatory Affairs SpecialistSan Jose, CAIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. What Your Day-To-Day Will Involve: Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT's products, marketing applications and post-market activities.
Principal Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesPrincipal Regulatory Affairs Specialist - Vascular (on-site)Santa Clara, CA$100,000–$200,000 / yearThe Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.
Regulatory Affairs Specialist III Thermo Fisher Scientific IncRegulatory Affairs Specialist IIIFremont, CA$90,900–$121,200 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
NewPrincipal Regulatory Affairs Specialist PROCEPT BioRobotics CorporationPrincipal Regulatory Affairs SpecialistSan Jose, CaliforniaIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Responsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelines.
Regulatory Affairs Specialist 4 eTeam Inc.Regulatory Affairs Specialist 4Sunnyvale, CA$58–$59 / hourStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. " Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
NewSenior Regulatory Affairs Specialist - Pleasanton, CA Calyxo IncSenior Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$145,000–$160,000 / yearRequirements: Master's degree with a minimum of 5 years of directly relevant regulatory affairs experience, or Bachelor's degree with a minimum of 8 years of directly relevant regulatory affairs experience, in the medical device, pharmaceutical, biotechnology, or in vitro diagnostics (IVD) industry, including experience with Class II or Class III electromechanical medical devices. In This Role, You Will: Prepare, author, and manage U.S. and international regulatory filings (including 510(k)s, letters to file, registrations/listings, and other regulatory submissions) with appropriate guidance for higher-risk or more complex issues, ensuring timely, high-quality deliverables.
Regulatory Affairs Specialist II Thermo Fisher Scientific IncRegulatory Affairs Specialist IIFremont, CA$72,000–$96,000 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Regulatory Affairs Specialist Abbott LaboratoriesRegulatory Affairs SpecialistPleasanton, CA$73,900–$116,000 / yearAt Abbott's Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment. Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Senior Regulatory Affairs Specialist Procept Biorobotics CorpSenior Regulatory Affairs SpecialistSan Jose, CA$148,550–$174,770 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
Staff Regulatory Affairs Specialist Procept Biorobotics CorpStaff Regulatory Affairs SpecialistCAWhat Your Day-To-Day Will Involve: Act as a lead regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.