- As a Senior Professional, a candidate will leverage candidate extensive expertise, integrating analysis, development, testing, and implementation within the candidate area of competence.
- Candidates will interpret and functionally influence policy and guidelines, developing processes and systems to deliver functional objectives.
- Planning candidate work according to agreed targets within a project-driven environment, candidates will provide functional advice and guidance to colleagues and customers.
- With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs.
- Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications, and EU MDR technical files.
- Candidate expertise includes determining product classification and whether product changes require regulatory submissions, particularly for software and hardware devices.
- Candidates have a solid understanding of relevant standards such as ISO 13485, IEC 62304, IEC 62366, ISO 14971, and ISO , demonstrated through coursework or submissions requiring the use of each standard.
- Candidate excellent communication and interpersonal skills enable seamless collaboration across departments and interaction with design and development teams.
- Proficient in utilizing business tools such as E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro, you leverage these tools effectively in candidate role.
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Senior Regulatory Affairs Specialist
3 weeks ago
CONFLUX SYSTEMS Palo Alto, United StatesHere are the job details for your review: · Job Title: Sr. Regulatory Affairs Specialist · Job Location : 911 Hansen Way, Bldg 3, Palo Alto, CA Hybrid) · Pay Rate: $68.89/HR on W2 · Duration: 12+ Months (Possibility of extension) · Client Name : Siemens · Shift Hours : 8am-5pm · ...
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Regulatory Affairs Specialist
2 weeks ago
Net2source Inc. Palo Alto, United StatesJob Title: Regulatory Affairs Professional 4Duration: 12 months (Possible Extension )Location: Palo Alto CA Hybrid)Experience: 5-8 years.Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various cont ...
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Senior Regulatory Affairs Specialist
1 week ago
Comrise Palo Alto, United StatesPayrate: 68.89/hr · Duration: 12 months · Position Description: · Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements · Identifies, analyzes and implements country specific requ ...
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Sr. Regulatory Affairs Specialist
1 week ago
Hired by Matrix Palo Alto, United StatesDo you want more than just another job? Are you ready to team up with an organization that values your contributions? Then Hired by Matrix is for you · Working with some of the US' premier companies, we excel at connecting candidates with positive cultures and dynamic teams · W ...
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Senior Regulatory Affairs Specialist
2 weeks ago
Comrise Palo Alto, United StatesPayrate: 68.89/hr · Duration: 12 months · Position Description: · Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements · Identifies, analyzes and implements country specific requirem ...
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Sr. Regulatory Affairs Specialist
3 weeks ago
Hired by Matrix Palo Alto, United StatesJob Description · Job Description · REMOTE Job · What You'll Do: · Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements. · Identifies, analyzes and implements country specific req ...
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Sr. Regulatory Affairs Specialist
2 days ago
estaffing Inc Palo Alto, United StatesJob Description · Job DescriptionPosition Description: · *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements · * Identifies, analyzes and implements country specific requirements n ...
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Principal Regulatory Affairs Specialist
2 weeks ago
BioLink 360 Mountain View, United StatesReports to: Senior Director of Regulatory and Quality · Salary Range: K · Location: San Jose, CA (hybrid position) · This is an established privately held medical device company with a focus in delivering innovative navigation diagnostic and therapeutic technologies. Their reach ...
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Sr. Regulatory Affairs Specialist
3 weeks ago
Hired by Matrix Palo Alto, United StatesDo you want more than just another job? Are you ready to team up with an organization that values your contributions? Then Hired by Matrix is for you · Working with some of the US' premier companies, we excel at connecting candidates with positive cultures and dynamic teams. We ...
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Sr. Regulatory Affairs Specialist
3 weeks ago
Hired by Matrix Palo Alto, United StatesDo you want more than just another job? Are you ready to team up with an organization that values your contributions? Then Hired by Matrix is for you · Working with some of the US' premier companies, we excel at connecting candidates with positive cultures and dynamic teams. We e ...
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Regulatory Affairs Specialist
1 week ago
GForce Life Sciences Santa Clara, United StatesRegulatory Affairs Specialist– Santa Clara, CA · Must be able to work on a W2 · Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and comme ...
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Senior Regulatory Affairs Specialist
3 weeks ago
Comrise Palo Alto, United StatesPayrate: 68.89/hr · Duration: 12 months · Position Description: · Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements · Identifies, analyzes and implements country specific requirem ...
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Senior Regulatory Affairs Specialist
2 weeks ago
Pulmonx Redwood City, United StatesPulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CA · Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. · Not sure who ...
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Senior Regulatory Affairs Specialist
1 week ago
Pulmonx Redwood City, United StatesPulmonx · is looking for an experienced · Sr Regulatory Affairs Specialist · to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: ...
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Senior Regulatory Affairs Specialist
2 weeks ago
Pulmonx Redwood City, United StatesPulmonx · is looking for an experienced · Sr Regulatory Affairs Specialist · to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: ...
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Regulatory Affairs Senior Specialist
2 weeks ago
Cepheid Sunnyvale, United StatesAt Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved ...
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Senior Regulatory Affairs Specialist
1 week ago
Pulmonx Redwood City, United StatesPulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CANot sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: and capabil ...
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Senior Regulatory Affairs Specialist
2 weeks ago
Pulmonx Redwood City, United StatesPulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: · Resp ...
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Senior Regulatory Affairs Specialist
19 hours ago
Nevro Redwood City, United StatesAbout Nevro: · Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The comp ...
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Regulatory Affairs Specialist
2 weeks ago
GForce Life Sciences Santa Clara, United StatesRegulatory Affairs Specialist II – Santa Clara, CA · Must be able to work on a W2 · Job Summary · We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting manu ...
Senior Regulatory Affairs Specialist - Palo Alto, United States - Cynet Systems
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Description
Job Description:Pay Range $63.89hr - $68.89hr
Responsibilities: