- Bachelor's Degree in Engineering or other Technical Science field
- 5+ years of work experience in a highly regulated industry as a regulatory affairs professional (e.g., Medical Devices, Bioengineering, Pharma, Life Sciences)
- Demonstrated success in the application of the MDD & EU MDR, FDA regulatory approval pathways DeNovo and 510k, and other worldwide regulators in particular for Software as a Medical Device (SaMD) products
- Proven communication skills. Experience presenting clearly and persuasively to technical and non-technical audience in an environment that is not medical device native
- Demonstrated success in authoring technical reports, business correspondence, regulatory applications, and standard operating procedures
- Master's Degree in Regulatory Affairs
- Regulatory Affairs Professionals Society Regulatory Affairs Certification Certification
- Experience with direct to consumer health wearables product both regulated and wellness
- Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables
- Act as the core team member for end-to-end Regulatory Affairs input and deliverables for new product introductions and product changes across the globe
- Ensure products are brought to market on time, and sustained throughout life cycle via compliant, novel regulatory strategies
- Collaborate proactively and establish strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities and other regulatory bodies) to ensure that requirements are known early during strategy development, enabling rapid market access to Meta Reality Labs products
- Lead and enable cross-functional partnerships between Regulatory Affairs and all key stakeholders including Legal, Engineering, Product Management, Quality Compliance, Clinical Affairs and other functions at all levels within the business
- Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System
- Review and approve marketing, advertising, promotional items and labeling for regulatory compliance
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This role is part of the global design and development teams supporting the Philips Oral Healthcare business unit, · which delivers power toothbrushes, power flossers and whitening solutions to millions of customers worldwide.This Regulatory Affairs Specialist will assist with im ...
Bothell $97,440 - $136,400 (USD)2 weeks ago
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We are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory strategies and manage product submissions for novel hardware and software as a medical device (SaMD) products for distribution into worldwide markets. · Act as the core ...
Redmond $118,000 - $173,000 (USD) Full time2 weeks ago
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As a temporary Clinical Affairs Specialist, you will use your strong prior planning, communication, and coordination skills to assist in the design, development and testing of Fujifilm Sonosite's point-of-care ultrasound systems. · ...
Bothell $34 - $40 (USD)3 weeks ago
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+ Develops and facilitates regulatory submissions for new products/solutions. · + Identifies potential regulatory approval risks based on changes in regulations... · + You're The Right Fit If you have a Bachelor's or Master's degree in Chemistry... ...
Bothell2 weeks ago
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We're looking for a Clinical Affairs Specialist to assist in the design, development, and testing of our point-of-care ultrasound systems. · ...
Bothell $34 - $40 (USD)3 weeks ago
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As a Clinical Affairs Specialist at Fujifilm Sonosite, you will use your strong planning skills to assist in designing ultrasound systems. · ...
Bothell3 weeks ago
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+ Clinical Affairs Specialist: As a Clinical Affairs Specialist, you will use your strong prior planning, communication, and coordination skills to assist in the design, development, and testing of Fujifilm Sonosite's point-of-care ultrasound systems. · 3-5 years of complex proje ...
Bothell $34 - $40 (USD) TEMPORARY3 weeks ago
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This is a temporary Clinical Affairs Specialist role at Fujifilm Sonosite where you will assist in the design and development of point-of-care ultrasound systems. · ...
Bothell $34 - $40 (USD) TEMPORARY3 weeks ago
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We reinvent how healthcare is delivered with point-of-care ultrasound technology. As a temporary Clinical Affairs Specialist, you will use your strong prior planning, communication, and coordination skills to assist in the design, development, · & testing of Fujifilm Sonosite's p ...
Bothell, WA3 weeks ago
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This position is responsible for regulatory submissions required to market medical devices in both the U.S. and Europe. · Prepare regulatory submissions required to market medical devices in both the U.S. and Europe. · Support international product registrations. · ...
Seattle2 weeks ago
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This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe. · ...
Seattle, WA2 weeks ago
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+Responsibilities:This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe... · Requirements: · B.S. degree or higher in a life science or technical discipline... · ...
Seattle, WA2 weeks ago
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We are delivering to customers and are excited for what's to come. · Come work on the Amazon Prime Air Team Check out more information about Prime Air on the About Amazon blog: · ...
Seattle $114,400 - $205,500 (USD)1 month ago
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We are delivering to customers and are excited for what's to come. · The Opportunity · As Amazon Prime Air expands its drone delivery service,This is a pivotal role in which you will shape the regulatory landscape for commercial drone delivery,You will serve as a bridge between A ...
Seattle1 month ago
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We are delivering to customers and are excited for what's to come. · Come work on the Amazon Prime Air Team Check out more information about Prime Air on the About Amazon blog: · Drive Regulatory Strategy: Set regulatory objectives and secure internal buy-in and support. · Serve ...
Seattle $133,800 - $231,300 (USD)1 month ago
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We are delivering to customers and are excited for what's to come. If you are seeking an iterative environment where you can drive innovation, apply state-of-the-art technologies to solve real world delivery challenges, and provide benefits to customers, Prime Air is the place fo ...
Seattle, WA1 month ago
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We are delivering to customers and are excited for what's to come. If you are seeking an iterative environment where you can drive innovation, apply state-of-the-art technologies to solve real world delivery challenges, and provide benefits to customers, Prime Air is the place fo ...
Seattle, WA1 month ago
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Microsoft's Corporate and External Legal Affairs (CELA) organization has an open role on the Infrastructure Legal Affairs team. · ...
Redmond, WA1 week ago
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Microsoft's Corporate and External Legal Affairs (CELA) organization has an open role on the Infrastructure Legal Affairs team. · This is an opportunity to support innovative data center projects around the world. ...
Redmond $147,000 - $258,000 (USD)1 month ago
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Microsoft Corporation has an immediate opening for a Law Enforcement Response Specialist to join its Law Enforcement and National Security (LENS) team.The successful candidate will be highly organized, motivated, and comfortable working both independently and as part of a global ...
Redmond $76,800 - $151,900 (USD)2 weeks ago
- Work in company
Principal Corporate Counsel, Infrastructure Legal Affairs
Only for registered members
This is an opportunity to ensure that Microsoft customers worldwide have the necessary cloud and AI infrastructure capacity to meet their needs and enable their AI transformation. · ...
Redmond $132,200 - $232,800 (USD) Full time1 month ago
Medical Devices, Regulatory Affairs Specialist - Redmond - Meta Platforms, Inc.
Description
We are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory strategies and manage product submissions for novel hardware and software as a medical device (SaMD) products for distribution into worldwide markets. You will apply your subject matter expertise in regulatory strategy and approvals to partner with cross-functional teams, enabling the launch of regulated medical devices. This role is within an organization primarily focused on consumer electronics but with an expanding medical device portfolio in wearables and artificial intelligence (AI) products.
Minimum Qualifications
Preferred Qualifications
Responsibilities
About Meta
Meta builds technologies that help people connect, find communities, and grow businesses. When Facebook launched in 2004, it changed the way people connect. Apps like Messenger, Instagram and WhatsApp further empowered billions around the world. Now, Meta is moving beyond 2D screens toward immersive experiences like augmented and virtual reality to help build the next evolution in social technology. People who choose to build their careers by building with us at Meta help shape a future that will take us beyond what digital connection makes possible today-beyond the constraints of screens, the limits of distance, and even the rules of physics.
Equal Employment Opportunity
Meta is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or other applicable legally protected characteristics. You may view our Equal Employment Opportunity notice here.
Meta is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, fill out the Accommodations request form.
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