- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director, Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device strategies as applicable, for the designated program to support clinical trials where necessary, and… more
- Terumo Neuro (Aliso Viejo, CA)
- **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing, and leading the strategy for worldwide product ... solutions. + Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects...by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications,… more
- Terumo Neuro (Aliso Viejo, CA)
- …operation process/documentation. Ensure seamless coordination across functions, particularly with R&D, Regulatory Affairs , Compliance, and TIS marketing teams to ... operations, or commercial support. 3. Experience in healthcare, biotech, or medical device industry. 4. Strong project coordination and written and verbal… more
- Terumo Neuro (Aliso Viejo, CA)
- …functionally with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues. ... related field. 2. Minimum six (6) years of relevant work experience in medical device industry. 3. Minimum one (1) year of management experience. 4. Knowledge of… more
- Teleflex (San Francisco, CA)
- …an optimal customer experience. Collaborating with Marketing, Sales, Engineering and Clinical & Medical Affairs on key projects and initiatives, the CSS utilizes ... dictate the work schedule. **Specialized Skills / Other Requirements** + 2+ years of Medical Device Industry experience. + 3+ years of experience in a business… more
- Oracle (Sacramento, CA)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Meta (Burlingame, CA)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... **Summary:** We're seeking a regulatory affairs specialist to join our medical ...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Actalent (Lake Forest, CA)
- … Regulatory reporting, Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device , Regulatory affairs , FDA CFR, CMC, ... Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global ...development and sustaining activities. - Strong understanding of global medical device regulations (eg, FDA CFR, EU… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, Regulatory Affairs , Device works with internal and external ... partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for … more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will consider other REGULATED Industry experience + ... abilities and a deep understanding of regulations pertaining to medical devices. The Senior Regulatory Affairs...of related regulatory submission experience from a medical device and/or IVD industry. + Ability… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will consider other REGULATED Industry experience + ... focus on regulatory affairs . + 3+ years of related regulatory submission experience from a medical device and/or IVD industry. + Ability to work in a… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Principal Regulatory Affairs Specialist- Shockwave Medical ** to join our team. The ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease… more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site ... glucose levels with our new sensing technology. This **Principal Regulatory Affairs Specialist** position is responsible for...Scientific writing experience. + Solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU)… more
- J&J Family of Companies (Irvine, CA)
- …in the medical device industry with at least four (4) years in Regulatory Affairs of Medical Devices. + Class III PMA experience is _preferred_ . ... containing software _preferred_ . + Proven expertise in all aspects of Regulatory Affairs , Submission Preparation, FDA Device Law/Regulations, Worldwide… more
- Abbott (Sylmar, CA)
- …in Mandarin + Previous regulatory compliance, R&D, and/or quality experience in medical device industry + Good working knowledge of the product development ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...Sylmar, CA currently has an opportunity for a Senior Regulatory Affairs Specialist-China. As a Senior … more
- Abbott (Alameda, CA)
- …+ Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at… more
- Abbott (Pleasanton, CA)
- …Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus + ... treatment. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team...+ Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …us. **The Associate Director of Regulatory Affairs ** will provide regulatory support for medical device systems within infusion technologies. The ... including at least 5 years in Regulatory Affairs . Must have hands-on experience with complex medical device systems and software, specifically Class II… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge... regulations and/or experience with EU and other international medical device regulations and submissions. + Ability… more
- Abbott (Pleasanton, CA)
- …discipline + 3+ years of related regulatory submission experience from a medical device and/or pharmaceutical industry + Familiar with relevant US/ EU ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...fingersticks. **WHAT YOU'LL DO** We are recruiting for a ** Regulatory Affairs Specialist II** to join our… more
