Senior Manager, Global Regulatory Strategy
3 weeks ago
Description
The Sr Manager Regulatory Affairs represents US regulatory affairs for device development projects. Responsible for development, communication, and execution of US regulatory strategic plans to Global Regulatory Lead (GRL) and project team. Plans and prepares (or oversees) complex regulatory submission documents primarily for US regulatory filings, ensures technical accuracy, and regulatory compliance. Ensures that applications are executed appropriately and submitted on time.
Directs communication and interactions with FDA, as primary contact for the related projects. Utilizing detailed, in-depth understanding of regulations for device products, leads, and participates in global regulatory product teams, interprets regulations, and provides regulatory guidance. Supports management with implementation of departmental strategies and policies.
Duties and Responsibilities:
Represents US Regulatory in project teams. Develops US regulatory filing strategy, with minimal supervision. Provides regulatory strategy and guidance to global product owner/project team in line with commercial objectives.
Works collaboratively with GRL/regulatory/cross functional team to resolve complex project issues.
Utilize US device regulatory expertise and extensive knowledge of requirements to strategically interpret, plan, and communicate with the team.
Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.
Ensures planned device development activities comply with US regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.
Plans and prepares (or oversees) complex regulatory documents for US (PMA, IDE, IDE supplements and annual reports, FDA meetings) and potentially OUS submissions, under minimal supervision.
Prepares clear, complete, and accurate documents that are logically constructed and comprehensive in content and on time.
Reviews labeling and packaging components for new products/indication extensions to ensure accuracy and compliance with regulations and aligned with the commercial needs.
Communicates planned/approved changes with operations, commercial, medical affairs, and marketing.
Effectively plan, organize, and conduct formal meetings with regulatory agencies. Be able to negotiate to ensure acceptance of appropriate regulatory strategy. Assures compliance with project team timelines and milestones.
Maintains professional relationships with functional areas outside regulatory.
Develops professional relationships with Health Authorities through supervised process.
Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities.
Assists in training and mentoring of personnel, performs peer review of documents, and may supervise as appropriate.
Fosters a dynamic working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging intra- and inter-departmental team members to meet and/or exceed expectations.
-
Senior Specialist, Regulatory Affairs
1 week ago
Irvine, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full timeSenior Specialist, Regulatory Affairs, Sustaining Products, THV The Regulatory Affairs Senior Specialist role is an outstanding opportunity to be a part of the Edwards Lifesciences Transcatheter Heart Valve (THV) program, one of the medical device industry’s most groundbreaking technological innovations. Edwards has a strong pipeline in this space and the...
-
Asset Strategy Leader
2 weeks ago
Irvine, California, United States AbbVie Full timeJob Description Purpose The Asset Strategy Leader is an experienced and established leader with the ability to influence across multiple functions and levels within Abbvie who serves as the matrix leader with overall accountability for an asset from discovery to end of life cycle. He / she guides and directs the creation and execution of a comprehensive...
-
Manager, Regulatory Affairs
3 weeks ago
Irvine, California, United States Allergan Aesthetics Full timeJob Description Description The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US regulatory filings. Utilizing...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Irvine, United States Infosoft, Inc. Full timeJob Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...
-
Senior Regulatory Affairs Specialist
1 week ago
Irvine, United States Infosoft, Inc. Full timeJob Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Irvine, United States Infosoft, Inc. Full timeJob Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...
-
Irvine, California, United States AbbVie Full timeJob Description The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Supports regulatory objectives for the management of IVD/CDx...
-
Senior Regulatory Affairs Specialist
6 days ago
Irvine, United States INTELLECTT INC Full timeRole : Sr Spec, Regulatory Affairs Location : Irvine, CA - 92606 Duration : 9+ Months on W2 Job Description: Key Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing...
-
Senior Regulatory Affairs Specialist
6 days ago
Irvine, United States Cynet Systems Full timeJob Description: Pay Range $44.60hr - $49.60hr Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy. Participate in providing guidance on strategies and...
-
Senior Director, CMC Regulatory Affairs
3 weeks ago
California, United States Allogene Therapeutics Full timeAbout Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...
-
Senior Regulatory Affairs Specialist
4 days ago
Irvine, United States Cynet Systems Full timeJob Description:Pay Range $44.60hr - $49.60hrResponsibilities:Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy.Participate in providing guidance on strategies and...
-
Senior Director Regulatory Affairs
1 week ago
California, United States EPM Scientific Full timeSummary: Our client, a clinical stage biopharmaceutical company based in California, is seeking an experienced and highly motivated, hands-on regulatory affairs leader to join their team. The successful candidate will be responsible for developing and implementing effective regulatory strategies to support the development of innovative cell...
-
Director/Senior Director, Regulatory Affairs
3 weeks ago
California, United States Avita Medical Full timeDirector/Senior Director, Regulatory Affairs – Irvine or Valencia Position summary: Plans, executes, and oversees daily activities associated with Global Regulatory Affairs. Primary responsibilities include guidance and mentoring of Regulatory staff and acting as Regulatory leader in the Medical, Legal and Regulatory Review process including review,...
-
Senior Regulatory Affairs Specialist
3 days ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity. Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning...
-
Senior Regulatory Affairs Specialist
4 weeks ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and...
-
Senior Regulatory Labeling Specialist
5 days ago
Irvine, United States Medtronic, plc Full timeHelp with development of US and International regulatory strategies for product submissions. Assist in keeping company informed of regulatory requirements in the US and International Regions Participate on Product Development teams, providing regulat Regulatory, Neuro, Senior, Specialist, International, Technical, Manufacturing, Technology
-
Senior Manager, Global Medical Communications
2 weeks ago
Irvine, California, United States AbbVie Full timeJob Description *Position can sit remotely in the U.S. The Senior Manager/Associate Director, Medical Communications Ad Promo, represents the Medical function in the Material Review Process to guarantee medical, clinical, and scientific data accuracy, relevance, objectivity, balance and alignment with product label. Functions as the lead medical reviewer...
-
Irvine, United States AbbVie, Inc Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...
