- Responsible for hiring, managing and prioritizing workload for any regulatory staff. Supervise the Quality Manager and oversee all Quality activities.
- Develop and maintain relationships with the Peripheral Vascular staff at the FDA.
- Develop and establish strategic regulatory plans and interfaces with project team members, to drive client corporate initiatives to completion.
- Assume a leadership role for project management. Works independently to represent regulatory affairs on project teams bringing novel products and manufacturing processes from concept, through development, to market. Ensures product registration requirements are understood by project teams in order to create technical reports during development that will support global registrations.
- Review and approves product labeling and marketing materials, including websites and social media. Initiates new package inserts and other required product labeling.
- Manage/prepares elements of regulatory submissions (e.g., IDEs, 510(k)s, HDEs, Technical Files and Design Dossiers)
- Manage preparation and submission of pre-submission packages, Humanitarian Use Device designation requests and Non-Significant Risk proposals to support regulatory and clinical activities for clients.
- Prepare regulatory/clinical strategy packages for executive review, including performing predicate research and relevant literature review from peer-reviewed journals.
- Review/participates in preparing design history file documentation, including verification/validation testing, biocompatibility, sterilization, transit and aging documentation, risk management documentation and device draft labeling.
- Review complaint files (including submission of MDRs, Vigilance Reports and Mandatory Problem Reports).
- Support regulatory field actions.
- Knowledge of FDA's Quality System Regulation (QSR) and the changing EU Medical Device Regulation (MDR) is required.
- High level of professionalism, including strong verbal and written skills, is mandatory.
- Strong leadership attributes are necessary. The ability and willingness to prerform activities at various levels, from administrative to strategic
- Candidate should possess exceptional project management and technical writing skills.
- Peripheral vascular experience highly desired. Relationships in the FDA with the PV regulators would be ideal
- Master's degree
-
Head of Regulatory Affairs and Quality
2 weeks ago
Russell Solutions Group Menlo Park, United StatesHead of Regulatory Affairs and QualityAbout This Role:We are seeking an experienced Head of RA/QA to support U.S. regulatory activities as well as be an individual contributor on regulatory projects. The Head of RA/QA will participate in he planning, development and execution of ...
-
Head of Quality and Regulatory Affairs
2 weeks ago
Applied StemCell Milpitas, United StatesApplied StemCell is a leading CRO and CDMO with deep scientific expertise in nonviral gene editing and iPSC product development. We offer comprehensive solutions including research products and services, process and analytical development, and cGMP clinical manufacturing for inno ...
-
Head of Quality and Regulatory Affairs
2 weeks ago
Applied StemCell Milpitas, United StatesApplied StemCell is a leading CRO and CDMO with deep scientific expertise in nonviral gene editing and iPSC product development. We offer comprehensive solutions including research products and services, process and analytical development, and cGMP clinical manufacturing for inno ...
-
SME of Regulatory Affairs and Quality
1 week ago
Pyramid Consulting, Inc Pleasanton, United StatesImmediate need for a talented SME of Regulatory Affairs and Quality. This is a 12+ Months Contract opportunity with long-term potential and is located in Pleasanton, CA (Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay R ...
-
Document Control Specialist
1 week ago
Actalent Menlo Park, United States Full timeJob Description: · Review and approve master batch records, labels, specifications and other · pre-production documents for Clinical/Commercial Drug Product in compliance · with FDA and international health agency requirements. · • Review executed production batch records, enviro ...
-
Cmc Technical Writing Manager
2 weeks ago
Orca Bio Menlo Park, United StatesOver one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease. · **Summary* ...
-
Academic Affairs Manager
2 weeks ago
Stanford University Stanford, United States**To be considered for this position, please submit both your resume and a cover letter detailing your interest and qualifications for the role.** · Reporting to the Vice Dean of the School of Medicine, the Office of Academic Affairs (OAA) is comprised of nine faculty Associate D ...
-
Lucile Packard Children's Hospital Palo Alto, United States**Clinical Services** · **1.0 FTE, 8 Hour Day Shift** · At Stanford Children's Health, we know world-renowned care begins with world-class caring. That's why we combine advanced technologies and breakthrough discoveries with family-centered care. It's why we provide our caregiver ...
-
Lucile Packard Children's Hospital Palo Alto, United States**Information Technology** · **1.0 FTE, 8 Hour Day Shift** · At Stanford Children's Health, we know world-renowned care begins with world-class caring. That's why we combine advanced technologies and breakthrough discoveries with family-centered care. It's why we provide our care ...
-
Supervisor, Decedent Affairs
3 hours ago
Stanford Health Care Palo Alto, United States1.0 FTE Full time Evening - 08 Hour R Onsite 84900 OFFICE OF DECEDENT AFFAIRS Allied Health 300 Pasteur Dr,PALO ALTO,California · If you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your be ...
-
Customer Relations Specialist
1 week ago
Exact Sciences Corporation Redwood City, United States**Help us change lives** · At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, ...
-
Revolution Medicines Redwood City, United StatesRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS p ...
-
BioSpace Foster City, CA, United StatesJob Details · Associate Director, US Medical Affairs, Patient Access, and Quality of Care - Viology Strategy · United States - Remote · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas o ...
-
BioSpace Foster City, United StatesJob Details · Associate Director, US Medical Affairs, Patient Access, and Quality of Care (PAQ) Virology Strategy · United States - California - Foster CityUnited States - New Jersey - Parsippany · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discover ...
-
DermBiont Emeryville, CA, United StatesOrganization: · DermBiont is a clinical stage biotech company with multiple active INDs enabling multiple Phase 2 clinical trials. Assuming positive results in the current trials the two lead products will advance to Phase 3 trials in the coming year or two. The two lead product ...
-
Gilead Sciences, Inc. Foster City, United States Full timeAssociate Director, US Medical Affairs, Patient Access, and Quality of Care - Viology Strategy · United States – Remote · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medica ...
-
Gilead Sciences, Inc. Foster City, United States Full timeAssociate Director, US Medical Affairs, Patient Access, and Quality of Care (PAQ) Virology Strategy · United States - California - Foster CityUnited States - New Jersey - Parsippany · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops an ...
-
Gilead Sciences, Inc. Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...
-
Associate Director, Drug Safety Operations
5 days ago
Iovance Biotherapeutics Inc San Carlos, United States**Overview** · The Director of Drug Safety Operations reports to the Head of Drug Safety Operations and will work collaboratively within the Drug Safety department, cross-functionally with other departments, and with partner companies to achieve department and company goals. · Th ...
-
Assistant QA Manager
1 week ago
Minaris Medical America Mountain View, United StatesThe Assistant QA Manager is located in Mountain View, CA. This position is responsible for ensuring compliance with all appropriate regulatory requirements; Providing regulatory support as part of FDA submission team as appropriate; Defending the company at Regulatory and Quality ...
Head of Regulatory Affairs and Quality - Menlo Park, United States - Russell Solutions Group
Description
Job Description
Job DescriptionHead of Regulatory Affairs and Quality
About This Role:
We are seeking an experienced Head of RA/QA to support U.S. regulatory activities as well as be an individual contributor on regulatory projects. The Head of RA/QA will participate in he planning, development and execution of regulatory submissions. The incumbent will drive all Regulatory Affairs tasks, projects, and operations and oversee all Quality activities. This person is also responsible for ensuring all activities are in compliance with Quality System requirements.
What You Will Do:
Qualifications
Required skills:
Director Level: Bachelor's degree in a technical-related field plus a minimum of 12 years of related work experience, or an equivalent combination of education and experience.
Senior Director/ VP Level: Bachelor's degree in a technical-related field plus a minimum of 15+ years of related work experience, or an equivalent combination of education and experience.
Experience in overseeing regulatory affairs initiatives and activities with responsibility for the strategic direction of the regulatory affairs function.
Requirements:
Preferred: